1 |
NCT02838758 |
Recruiting |
Compare Ultrasound Assisted Cold Therapy and Lidocaine Injection to Treat Morton's Neuroma |
|
- Device: Cryoablation
- Drug: Lidocaine
- Drug: Saline
|
Interventional |
Phase 1 |
- Icahn School of Medicine at Mount Sinai
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Numeric Pain Rating Scale
- Lower extremity functional scale (LEFS)
|
66 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02838758 |
GCO 16-1139 |
|
July 2016 |
December 2018 |
December 2020 |
July 20, 2016 |
November 1, 2017 |
|
- Icahn School of Medicine at Mount Sinai
New York, New York, United States
|
2 |
NCT03046108 |
Recruiting |
Blind and Ultrasound Guided Injection in Morton Neuroma |
|
- Device: blind injection of Morton neuroma
- Drug: blind injection of Mepivacaine
- Drug: blind injection of Triamcinolone
- (and 3 more...)
|
Interventional |
Phase 4 |
- Complejo Hospitalario Universitario de Granada
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Pain (VAS score)
- Manchester foot pain and disability index
- Generic quality-of-life instrument, the EQ-5D
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT03046108 |
0565-N-16 |
|
January 2016 |
August 2018 |
August 2018 |
February 8, 2017 |
October 18, 2017 |
|
- Complejo Hospitalario Universitario Granada
Granada, SPA, Spain
|
3 |
NCT03057678 |
Not yet recruiting |
Evaluating the Pre-Positioning Frame for Robotic Acoustic Neuroma Removal Surgery |
|
- Other: Testing of Pre-Positioning Frame
|
Interventional |
Not Applicable |
- Vanderbilt University Medical Center
- National Institute on Deafness and Other Communication Disorders (NIDCD)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Time in minutes required to attach the PPF.
- Percentage of planned mastoidectomy reachable by robot
|
10 |
All |
21 Years to 80 Years (Adult, Senior) |
NCT03057678 |
151347 R01DC012593 |
PPF |
December 2018 |
July 2020 |
July 2020 |
February 20, 2017 |
January 25, 2018 |
|
- Vanderbilt University Medical Center
Nashville, Tennessee, United States
|
4 |
NCT01129687 |
Recruiting |
Subtotal Resection of Large Acoustic Neuromas With Possible Stereotactic Radiation Therapy |
|
- Procedure: Microsurgery
- Procedure: Stereotactic radiation therapy
|
Observational |
|
- Stanford University
- University of Cincinnati
- Baylor College of Medicine
- (and 6 more...)
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Need for stereotactic radiation therapy should tumor remnant grow on annual MRI's
- Facial nerve function measured on House-Brackmann scale
|
200 |
All |
18 Years and older (Adult, Senior) |
NCT01129687 |
SU-03052010-5142 |
|
March 2005 |
March 2025 |
March 2025 |
May 25, 2010 |
April 26, 2017 |
|
- Stanford University School of Medicine
Stanford, California, United States - George Washington University
Washington, D.C., District of Columbia, United States - Indiana University
Indianapolis, Indiana, United States - (and 6 more...)
|
5 |
NCT02930551 |
Recruiting |
Neuromas as the Cause of Pain |
|
- Drug: Lidocaine
- Drug: Isotonic Saline
|
Interventional |
Not Applicable |
- Danish Pain Research Center
- Aarhus University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Diagnostic
|
- Spontaneous pain on numerical rating scale (NRS 0-10)
- Evoked pain on numerical rating scale (NRS 0-10)
- Brush allodynia
- (and 3 more...)
|
24 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT02930551 |
Neurom2016 |
|
September 2016 |
December 2018 |
June 2019 |
October 12, 2016 |
October 23, 2017 |
|
- Danish Pain Research Center, Aarhus University Hospital
Aarhus, Denmark
|
6 |
NCT03051113 |
Recruiting |
Identification of Neuromas by High Resolution Ultrasound in Patients With Peripheral Nerve Injury and Amputations |
|
|
Observational |
|
- Danish Pain Research Center
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Prevalence of neuromas in patients with pain and without pain after peripheral nerve injury or amputation.
|
60 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT03051113 |
NeuromUL2016 |
|
August 2016 |
December 2018 |
December 2018 |
February 13, 2017 |
February 13, 2017 |
|
- Danish Pain Research Center, Aarhus University Hospital
Aarhus, Denmark
|
7 |
NCT03393689 |
Recruiting |
RGD PET/MRI in Sporadic Vestibular Schwannoma |
|
- Drug: One injection of 68Ga-NODAGA-E[c(RGDyK)]2
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Angiogenesis PET/MR imaging of patients with sporadic Vestibular Schwannomas
|
40 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT03393689 |
PCT2017-1 2017-002604-27 |
|
January 2, 2018 |
January 2, 2021 |
January 2, 2021 |
January 8, 2018 |
January 10, 2018 |
|
- Department of Otolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet
Copenhagen, Denmark
|
8 |
NCT02055859 |
Recruiting |
Cyberknife Radiosurgery for Patients With Neurinomas |
- Sporadic Acoustic Neuromas
- Useful Hearing
|
|
Interventional |
Phase 3 |
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Useful hearing preservation after single or multisession radiosurgery
- treatment effectiveness
- treatment safety
|
102 |
All |
18 Years and older (Adult, Senior) |
NCT02055859 |
PR-Rt acouneu |
ACOUNEU |
April 2011 |
November 2018 |
November 2021 |
February 5, 2014 |
October 16, 2015 |
|
- Istittuto Nazionale Neurologico Carlo Besta
Milano, Mi, Italy
|
9 |
NCT03260400 |
Recruiting |
Short-term Implanted Electrodes Following Regenerative Peripheral Nerve Surgery for Improving Prosthetic Limb Control Signals |
- Amputation Neuroma
- Amputation
|
- Device: a bipolar percutaneous intramuscular electromyography electrode
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Change in Pain Level as measured by SF-36
- Change in Pain Level as measured by LANSS surveys
- RPNI tissue degeneration measured by volume during ultrasound
- (and 3 more...)
|
10 |
All |
22 Years and older (Adult, Senior) |
NCT03260400 |
HUM00124839 |
|
July 19, 2017 |
July 2023 |
July 2023 |
August 24, 2017 |
August 24, 2017 |
|
- University of Michigan
Ann Arbor, Michigan, United States
|
10 |
NCT03255395 |
Recruiting |
Focused Ultrasound Treatment of Stump Neuromas for the Relief of Chronic Post-Amputation Neuropathic Pain |
- Phantom Limb Pain
- Residual Limbs
- Amputation
|
- Device: Magnetic resonance-guided focused ultrasound
|
Interventional |
Not Applicable |
- Rambam Health Care Campus
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change from baseline in the average daily pain
|
10 |
All |
18 Years and older (Adult, Senior) |
NCT03255395 |
180-16 |
|
April 24, 2017 |
April 2019 |
April 2019 |
August 21, 2017 |
August 30, 2017 |
|
- Rambam Health Care Campus
Haifa, Israel
|
11 |
NCT02948790 |
Not yet recruiting |
Auditory Nerve Monitoring Using Intra-cochlear Stimulation in Subjects With Acoustic Neuroma |
- Hearing Loss, Cochlear
- Neurinoma of the Acoustic Nerve
|
- Device: Neuristim
- Device: Cochlear implant
|
Interventional |
Not Applicable |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Wave V latency
- Complications
- Impedance measurement
- (and 3 more...)
|
34 |
All |
18 Years and older (Adult, Senior) |
NCT02948790 |
PIC_05 |
NeuriStim |
March 2017 |
January 2019 |
May 2019 |
October 28, 2016 |
February 28, 2017 |
|
|
12 |
NCT01199978 |
Recruiting |
Hearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma |
- Vestibular Schwannoma
- Acoustic Neuroma
|
- Radiation: Fractionated proton radiation
|
Interventional |
Phase 2 |
- Massachusetts General Hospital
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Characterization of long-term hearing effects
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT01199978 |
10-218 |
|
September 2010 |
December 2018 |
December 2018 |
September 13, 2010 |
December 21, 2017 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States
|
13 |
NCT03261726 |
Recruiting |
Maintaining Cochlear Patency After VIIIth Nerve Surgery |
- Acoustic Neuroma
- Labyrinthitis Ossificans
- Profound Hearing Impairment
|
- Device: MedEl Test Electrode Placer
|
Interventional |
Not Applicable |
- Eric W. Sargent, MD
- Med-El Corporation
- Ascension St John Providence
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of Treatment-Emergent Adverse Events related to implanted insertion electrode
- Presence or absence of fluid in the cochlea
|
15 |
All |
Child, Adult, Senior |
NCT03261726 |
IRB# 1040241 |
|
August 4, 2017 |
August 4, 2020 |
February 1, 2021 |
August 25, 2017 |
August 28, 2017 |
|
- The Michigan Ear Institute
Farmington Hills, Michigan, United States
|
14 |
NCT02986919 |
Recruiting |
Study of CPI-0610 in Patients With Malignant Peripheral Nerve Sheath Tumors |
|
|
Interventional |
Phase 2 |
- University of Texas Southwestern Medical Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Response rate of CPI-0610
- Duration of CPI-0610
- Adverse events associated with CPI-0610
- Correlate tumor exposure to CPI-0610 with tumor BIM1 expression
|
24 |
All |
18 Years and older (Adult, Senior) |
NCT02986919 |
STU 092016-074 |
|
May 5, 2017 |
March 2019 |
March 2020 |
December 8, 2016 |
November 20, 2017 |
|
- University of Texas Southwestern Medical Center
Dallas, Texas, United States
|
15 |
NCT03210285 |
Not yet recruiting |
WES of NF2-associated in Comparison to Sporadic Vestibular Schwannomas - Correlation With Clinical Data |
- Neurofibromatosis Type 2
- Vestibular Schwannoma
- Acoustic Neuroma
|
- Diagnostic Test: Whole exome sequencing
|
Observational |
|
- University Hospital Tuebingen
- National Center for Tumor Diseases, Heidelberg
|
Other |
- Observational Model: Case-Control
- Time Perspective: Other
|
- Correlation clinical-volumetric pathologies and distinct genetic features
- Identification of genetic profiles for pre-interventional prediction of expected disease progression
|
100 |
All |
up to 99 Years (Child, Adult, Senior) |
NCT03210285 |
NF2Tue |
NF2 |
July 31, 2017 |
September 1, 2018 |
September 1, 2021 |
July 6, 2017 |
July 6, 2017 |
|
- University Department of Neurosurgery Tübingen
Tübingen, Germany
|
16 |
NCT03079999 |
Not yet recruiting |
Study of Aspirin in Patients With Vestibular Schwannoma |
- Vestibular Schwannoma
- Acoustic Neuroma
- Neurofibromatosis 2
|
- Drug: Aspirin
- Drug: Placebo
|
Interventional |
Phase 2 |
- Massachusetts Eye and Ear Infirmary
- United States Department of Defense
- Massachusetts General Hospital
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Progression Free Survival
|
300 |
All |
12 Years and older (Child, Adult, Senior) |
NCT03079999 |
17-030 |
|
April 2018 |
February 2021 |
February 2022 |
March 15, 2017 |
March 5, 2018 |
|
|
17 |
NCT03228511 |
Not yet recruiting |
Endoscopic-assisted Microsurgical Removal of Cerebellopontine Angle Lesions |
- Cerebellopontine Angle Tumor
|
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- post operative residual tumor
|
1 |
All |
Child, Adult, Senior |
NCT03228511 |
Easpost fossa |
|
August 1, 2017 |
January 2021 |
March 2021 |
July 25, 2017 |
July 25, 2017 |
|
|
18 |
NCT02282917 |
Recruiting |
Exploratory Evaluation of AR-42 Histone Deacetylase Inhibitor in the Treatment of Vestibular Schwannoma and Meningioma |
- Vestibular Schwannoma
- Meningioma
- Acoustic Neuroma
- Neurofibromatosis Type 2
|
|
Interventional |
Early Phase 1 |
- Massachusetts Eye and Ear Infirmary
- Johns Hopkins University
- Mayo Clinic
- (and 3 more...)
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Expression levels of phospho-Akt (p-AKT) and p16INKA after 3 weeks of oral AR-42
- Biological effects onPI3K (including levels of p-AKT, total AKT, p-PRAS-40, total PRAS-40, p-S6 ribosomal protein, and p-4E-BP-1)
- Biological effects on tumor proliferation (as assessed by Ki-67 proliferation index), etc.
- (and 5 more...)
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT02282917 |
14-078H |
|
September 2015 |
August 2018 |
August 2018 |
November 5, 2014 |
December 13, 2017 |
|
- Stanford University
Stanford, California, United States - Johns Hopkins University
Baltimore, Maryland, United States - Massachusetts Eye and Ear
Boston, Massachusetts, United States - Mayo Clinic
Rochester, Minnesota, United States
|
19 |
NCT02415257 |
Recruiting |
Gentamicin Treatment Prior to Schwannoma Surgery - No Residual Function |
|
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Differences and changes of postural control following surgery, compared to before surgery
- Occurrence of spontaneous nystagmus after surgery
- Change of hearing levels
- (and 10 more...)
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT02415257 |
VS-FT-02 |
|
April 2015 |
April 2020 |
December 2020 |
April 14, 2015 |
September 7, 2016 |
|
- Dept. OtoRhinoLaryngology Head and Neck Surgery, Skane University Hospital
Lund, Sweden
|
20 |
NCT02379754 |
Recruiting |
Gentamicin Treatment Prior to Schwannoma Surgery - Residual Function |
|
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Differences and changes of postural control following surgery, compared to before surgery
- Differences of duration of hospital stay
- Differences of subjective well being after surgery
- (and 10 more...)
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT02379754 |
VS-FT-01 |
|
January 2015 |
February 2018 |
December 2018 |
March 5, 2015 |
September 7, 2016 |
|
- Dept. OtoRhinoLaryngology Head and Neck Surgery, Skane University Hospital
Lund, Sweden
|
21 |
NCT03504462 |
Not yet recruiting New |
Feasibility of Specific Anesthesia of the Forefoot Preserving the Sensitivity of the Heel for Foot Surgery |
- Hallux Valgus and Bunion (Disorder)
- Morton Neuroma
- Metatarsal Fracture
- (and 3 more...)
|
- Procedure: Specific block of medial and lateral plantar nerves
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Feasibility of a specific block of the lateral and medial plantar nerves
- Feasibility of the foot surgery with a specific block of the lateral and medial plantar nerves
- Ability to recognize plantar nerves under ultrasound
- (and 3 more...)
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT03504462 |
2018/03 |
DISTIB |
May 1, 2018 |
April 1, 2019 |
May 1, 2019 |
April 20, 2018 |
April 23, 2018 |
|
- CMC Ambroise Paré
Neuilly-sur-Seine, Ile-de-France, France
|
22 |
NCT03346889 |
Recruiting |
Vestibular Outcomes in Vestibular Schwannoma |
|
|
Observational |
|
- Haukeland University Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Dizziness Handicap Inventory (DHI)
- Vertigo Symptom Scale Short Form
- Haukeland Dizziness Questionnaire (HDQ-10)
- (and 3 more...)
|
150 |
All |
Child, Adult, Senior |
NCT03346889 |
2017/765 C |
VOVS |
April 23, 2017 |
December 31, 2018 |
July 1, 2019 |
November 20, 2017 |
November 30, 2017 |
|
- Haukeland University Hospital
Bergen, Hordaland, Norway
|
23 |
NCT03097822 |
Not yet recruiting |
Response Prediction After GKS in Patients With Vestibular Schwannoma Using DCE MR Imaging |
|
|
Observational |
|
- Seoul National University Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Tumor size change before and after surgery
- In patients who underwent gamma knife surgery, the magnitude of tumor size change before and after surgery
|
90 |
All |
20 Years and older (Adult, Senior) |
NCT03097822 |
H-1611-087-809 |
|
January 2017 |
December 2018 |
|
March 31, 2017 |
March 31, 2017 |
|
|
24 |
NCT02275325 |
Recruiting |
Preoperative Vestibular Rehabilitation Effectiveness After Vestibular Schwannoma Surgery |
|
- Other: Preoperative vestibular rehabilitation
|
Interventional |
Not Applicable |
- Central Hospital, Nancy, France
- University of Lorraine
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Acute balance compensation
- Balance compensation at short term
- Balance compensation at middle term
- (and 15 more...)
|
50 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02275325 |
2014-A01189-38 140989B-31 |
ReveSTAN |
January 2015 |
April 2018 |
April 2019 |
October 27, 2014 |
June 21, 2016 |
|
- University Hospital of Nancy
Nancy, France
|
25 |
NCT02249572 |
Recruiting |
Vestibular Schwannoma - Radiosurgery or Expectation: V-REX. |
|
- Radiation: gamma knife radiosurgery
|
Interventional |
Phase 2 Phase 3 |
- Haukeland University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Relative Tumor volume
- Hearing acuity
- Conversion to other treatment during study period
- Subjective complaints
|
100 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02249572 |
2014/314 |
V-REX |
October 2014 |
December 2017 |
December 2021 |
September 25, 2014 |
March 1, 2016 |
|
- Haukeland Unviersity Hospital
Bergen, Norway
|
26 |
NCT03484429 |
Recruiting New |
Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain |
- Phantom Limb Pain
- Postoperative Pain
- Neuroma
- (and 4 more...)
|
- Device: Peripheral nerve stimulation
- Other: Standard Medical Therapy
|
Interventional |
Not Applicable |
- Hunter Holmes Mcguire Veteran Affairs Medical Center
|
U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change from Baseline in Residual Limb Pain
- Change from Baseline in Phantom Limb Pain
- Change from Baseline in Interference of daily activities due to pain
- (and 5 more...)
|
16 |
All |
18 Years to 79 Years (Adult, Senior) |
NCT03484429 |
2343 |
|
December 1, 2017 |
March 1, 2019 |
March 1, 2019 |
March 30, 2018 |
March 30, 2018 |
|
- Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States
|
27 |
NCT02934256 |
Recruiting |
Icotinib Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors |
- Vestibular Schwannoma
- Neurofibromatosis Type 2
|
|
Interventional |
Phase 2 |
- Li Peng
- Betta Pharmaceuticals Co.,Ltd.
- Beijing Tiantan Hospital
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change from Baseline in volume of tumour after every course of the treatment
- Change from Baseline in hearing ability after every course of the treatment
|
20 |
All |
16 Years to 50 Years (Child, Adult) |
NCT02934256 |
Tian-drug-neuro002 |
Icotinib |
July 2016 |
January 2018 |
June 2018 |
October 14, 2016 |
February 9, 2017 |
|
- Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing, China - Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, China
|
28 |
NCT02129647 |
Recruiting |
Study of Axitinib in Patients With Neurofibromatosis Type 2 and Progressive Vestibular Schwannomas |
- Neurofibromatosis Type 2
- Vestibular Schwannomas
|
|
Interventional |
Phase 2 |
- New York University School of Medicine
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Radiographic tumor response (i.e. maximum tumor shrinkage)
- Audiologic response
|
17 |
All |
18 Years and older (Adult, Senior) |
NCT02129647 |
14-00004 |
|
April 2014 |
January 2019 |
January 2019 |
May 2, 2014 |
March 29, 2018 |
|
- NYU Langone Medical Center
New York, New York, United States
|
29 |
NCT03095248 |
Recruiting |
Trial of Selumetinib in Patients With Neurofibromatosis Type II Related Tumors |
- Neurofibromatosis 2
- Vestibular Schwannoma
- Meningioma
- (and 2 more...)
|
|
Interventional |
Phase 2 |
- Children's Hospital Medical Center, Cincinnati
- AstraZeneca
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in hearing response at 24 weeks
- Response rate of other NF2 related tumors
- Response rate of vestibular schwannomas
- Change in quality of life
|
34 |
All |
3 Years to 45 Years (Child, Adult) |
NCT03095248 |
SEL-TH-1601 2016-8833 |
SEL-TH-1601 |
May 8, 2017 |
May 2020 |
May 2021 |
March 29, 2017 |
May 11, 2017 |
|
- Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
|
30 |
NCT03406208 |
Recruiting |
Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing |
- Neurofibromatoses
- Neurofibromatosis 1
- Neurofibromatosis 2
- Schwannomatosis
|
- Behavioral: Stress and Symptom Management Program 1
- Behavioral: Stress and Symptom Management Program 2
|
Interventional |
Not Applicable |
- Massachusetts General Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Change in Physical Quality of Life
- Change in Psychological Quality of Life
- Social Quality of Life
- (and 12 more...)
|
224 |
All |
18 Years and older (Adult, Senior) |
NCT03406208 |
2017P000143 |
|
October 1, 2017 |
January 30, 2022 |
January 30, 2022 |
January 23, 2018 |
January 23, 2018 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States
|
31 |
NCT03050268 |
Recruiting |
Familial Investigations of Childhood Cancer Predisposition |
- Acute Leukemia
- Adenomatous Polyposis
- Adrenocortical Carcinoma
- (and 43 more...)
|
|
Observational |
|
- St. Jude Children's Research Hospital
|
Other |
- Observational Model: Family-Based
- Time Perspective: Prospective
|
- Identification of novel cancer predisposing genes
|
3000 |
All |
Child, Adult, Senior |
NCT03050268 |
SJFAMILY |
SJFAMILY |
April 6, 2017 |
March 31, 2037 |
March 31, 2037 |
February 10, 2017 |
January 5, 2018 |
|
- St. Jude Children's Research Hospital
Memphis, Tennessee, United States
|
32 |
NCT02811718 |
Recruiting |
Resiliency Training for Patients With NF2 Via Videoconferencing With Skype |
|
- Behavioral: Stress Management Group 1
- Behavioral: Stress Management Group 2
|
Interventional |
Not Applicable |
- Massachusetts General Hospital
- The Children's Tumor Foundation
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Quality of Life (WHOQOL-BREF)
- Penn Acoustic Neuroma Quality-of Life Scale (PANQOL)
- Perceived Stress Scale (PSS-10)
- (and 7 more...)
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT02811718 |
2013P002605b |
|
July 2016 |
June 2018 |
June 2018 |
June 23, 2016 |
April 4, 2017 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States
|
33 |
NCT01885767 |
Recruiting |
Neurofibromatosis (NF) Registry Portal |
- Neurofibromatosis 1
- Neurofibromatosis 2
- Schwannomatosis
|
|
Observational |
|
- The Children's Tumor Foundation
|
Other |
- Observational Model: Case-Only
- Time Perspective: Other
|
- to determine the natural history of NF1, NF2, and schwannomatosis
|
10000 |
All |
Child, Adult, Senior |
NCT01885767 |
CTF001 |
|
June 2012 |
June 2022 |
June 2050 |
June 25, 2013 |
January 25, 2018 |
|
- Children's Tumor Fundation
New York, New York, United States
|
34 |
NCT03433183 |
Not yet recruiting |
SARC031: MEK Inhibitor Selumetinib (AZD6244) in Combination With the Dual mTOR Kinase Inhibitor Vistusertib (AZD2014) for Patients With Malignant Peripheral Nerve Sheath Tumors |
- Malignant Peripheral Nerve Sheath Tumors
- Neurofibromatosis 1
|
- Drug: Selumetinib
- Drug: Vistusertib
|
Interventional |
Phase 2 |
- Sarcoma Alliance for Research through Collaboration
- United States Department of Defense
- AstraZeneca
|
Other / U.S. Fed / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Clinical benefit rate of selumetinib in combination with vistusertib in patients with unresectable or metastatic NF1 associated or sporadic MPNST.
- Progression free and overall survival
- Define and describe the toxicities of selumetinib in combination with vistusertib in patients with unresectable or metastatic NF1 associated or sporadic MPNST.
- (and 2 more...)
|
21 |
All |
12 Years and older (Child, Adult, Senior) |
NCT03433183 |
SARC031 CDMRP-NF150092 |
|
May 2018 |
September 2021 |
September 2021 |
February 14, 2018 |
April 13, 2018 |
|
|
35 |
NCT03215511 |
Recruiting |
Phase 1/2 Study of LOXO-195 in Patients With Previously Treated NTRK Fusion Cancers |
- Carcinoma, Non-Small-Cell Lung
- Thyroid Neoplasms
- Sarcoma
- (and 32 more...)
|
|
Interventional |
Phase 1 Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum Tolerated Dose (MTD)
- Recommended dose for further study in patients age 12 and older and age <12
- Best overall response of confirmed PR or CR by independent radiology review in patients age 12 and older and age <12 in NTRK fusion cancer patients previously treated with TRK inhibitor who have progressed
- (and 14 more...)
|
93 |
All |
1 Month and older (Child, Adult, Senior) |
NCT03215511 |
LOXO-EXT-17005 |
|
July 10, 2017 |
August 2019 |
December 2019 |
July 12, 2017 |
March 1, 2018 |
|
- Stanford Cancer Center
Stanford, California, United States - Massachusetts General Hospital
Boston, Massachusetts, United States - Memorial Sloan Kettering Cancer Center
New York, New York, United States - MD Anderson Cancer Center
Houston, Texas, United States
|
36 |
NCT03141021 |
Recruiting |
Multi-Institutional Registry for Malignant Peripheral Nerve Sheath Tumors |
- Malignant Peripheral Nerve Sheath Tumors
|
|
Observational |
|
- Washington University School of Medicine
|
Other |
- Observational Model: Cohort
- Time Perspective: Other
|
- Histologic characteristics of malignant peripheral nerve sheath tumor (MPNST)
- Immunohistochemical characteristics of malignant peripheral nerve sheath tumor (MPNST)
- Molecular characteristics of malignant peripheral nerve sheath tumor (MPNST)
- (and 3 more...)
|
1000 |
All |
Child, Adult, Senior |
NCT03141021 |
201702006 |
|
April 28, 2017 |
April 28, 2027 |
April 28, 2027 |
May 4, 2017 |
April 18, 2018 |
|
- National Institutes of Health (NIH)
Bethesda, Maryland, United States - Washington University School of Medicine
Saint Louis, Missouri, United States - Memorial Sloan Kettering Cancer Center
New York, New York, United States
|
37 |
NCT03009201 |
Recruiting |
Ribociclib and Doxorubicin in Treating Patients With Metastatic or Advanced Soft Tissue Sarcomas That Cannot Be Removed by Surgery |
- Metastatic Angiosarcoma
- Metastatic Epithelioid Sarcoma
- Metastatic Fibrosarcoma
- (and 10 more...)
|
- Drug: Doxorubicin
- Drug: Ribociclib
|
Interventional |
Phase 1 |
- OHSU Knight Cancer Institute
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of DLTs of adverse events graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03
- Incidence of adverse events, SAEs, assessed by NCI CTCAE v 4.03
- Incidence of dose modifications (interruptions, reductions, intensity) due to adverse events
- (and 2 more...)
|
36 |
All |
12 Years and older (Child, Adult, Senior) |
NCT03009201 |
STUDY00016070 NCI-2016-01794 P30CA069533 |
|
January 2017 |
December 2018 |
December 2020 |
January 4, 2017 |
November 6, 2017 |
|
- OHSU Knight Cancer Institute
Portland, Oregon, United States
|
38 |
NCT02834013 |
Recruiting |
Nivolumab and Ipilimumab in Treating Patients With Rare Tumors |
- Acinar Cell Carcinoma
- Adenoid Cystic Carcinoma
- Adrenal Cortex Carcinoma
- (and 82 more...)
|
- Procedure: Biospecimen Collection
- Biological: Ipilimumab
- Biological: Nivolumab
|
Interventional |
Phase 2 |
- National Cancer Institute (NCI)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall response rate (ORR) defined as confirmed and unconfirmed complete and partial response
- Incidence of adverse events graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- Best response calculated from the sequence of RECIST 1.1 and immune-related response criteria (irRC) objectives
- (and 3 more...)
|
707 |
All |
18 Years and older (Adult, Senior) |
NCT02834013 |
NCI-2016-01041 S1609 U10CA180888 |
|
January 13, 2017 |
August 31, 2020 |
|
July 15, 2016 |
April 24, 2018 |
|
- University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States - University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States - Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States - (and 815 more...)
|
39 |
NCT02700230 |
Recruiting |
Vaccine Therapy in Treating Patients With Malignant Peripheral Nerve Sheath Tumor That is Recurrent or Cannot Be Removed by Surgery |
- Metastatic Malignant Peripheral Nerve Sheath Tumor
- Neurofibromatosis Type 1
- Recurrent Malignant Peripheral Nerve Sheath Tumor
|
- Procedure: Computed Tomography
- Other: Laboratory Biomarker Analysis
- Biological: Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter
- (and 2 more...)
|
Interventional |
Phase 1 |
- Mayo Clinic
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Best response using the World Health Organization response criteria
- Incidence of adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
- Maximum tolerated dose defined as the highest safely tolerated dose level where at most 1 out of 6 patients experience dose-limiting toxicity (DLT) with the next higher dose having at least 2 patients out of a maximum of 6 patients experience DLT
- (and 12 more...)
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT02700230 |
MC1372 NCI-2016-00179 P30CA015083 |
|
December 8, 2017 |
June 15, 2021 |
June 15, 2021 |
March 7, 2016 |
February 6, 2018 |
|
- Mayo Clinic
Rochester, Minnesota, United States
|
40 |
NCT02691026 |
Recruiting |
A Study of Pembrolizumab in Patients With Malignant Peripheral Nerve Sheath Tumor (MPNST), Not Eligible for Curative Surgery |
- Malignant Peripheral Nerve Sheath Tumour (MPNST)
|
|
Interventional |
Phase 2 |
- Oslo University Hospital
- Merck Sharp & Dohme Corp.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of patients with at least stable disease after 18 weeks of treatment assessed by RECIST 1.1.
|
18 |
All |
18 Years and older (Adult, Senior) |
NCT02691026 |
MK3475_MPNST |
|
June 2016 |
December 2018 |
December 2025 |
February 24, 2016 |
October 17, 2017 |
|
- Oslo university Hospital
Oslo, Norway
|
41 |
NCT02601209 |
Recruiting |
Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma |
- High Grade Sarcoma
- Metastatic Leiomyosarcoma
- Metastatic Malignant Peripheral Nerve Sheath Tumor
- (and 8 more...)
|
- Drug: Pazopanib Hydrochloride
- Drug: Sapanisertib
|
Interventional |
Phase 1 Phase 2 |
- National Cancer Institute (NCI)
|
NIH |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose of sapanisertib (Phase I)
- Progression-free survival (PFS) (Phase II)
- Incidence of adverse events graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- (and 5 more...)
|
137 |
All |
18 Years and older (Adult, Senior) |
NCT02601209 |
NCI-2015-01929 A091304 U10CA180821 |
|
November 30, 2015 |
September 1, 2020 |
|
November 10, 2015 |
April 24, 2018 |
|
- University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States - Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States - Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States - (and 419 more...)
|
42 |
NCT02584647 |
Recruiting |
PLX3397 Plus Sirolimus in Unresectable Sarcoma and Malignant Peripheral Nerve Sheath Tumors |
- Sarcoma
- Malignant Peripheral Nerve Sheath Tumors
|
- Drug: PLX3397
- Drug: Sirolimus
|
Interventional |
Phase 1 Phase 2 |
- Gulam Manji
- Plexxikon
- Columbia University
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose (MTD, in milligrams) of PLX3397 in combination with Sirolimus
- Overall survival rate
- Progression free survival (PFS) rate
|
49 |
All |
18 Years and older (Adult, Senior) |
NCT02584647 |
AAAO6059 R01FD005745 |
PLX3397 |
November 4, 2015 |
October 2018 |
October 2021 |
October 22, 2015 |
February 1, 2018 |
|
- Early Drug Development Center
Boston, Massachusetts, United States - Washington University in St. Louis
Saint Louis, Missouri, United States - Columbia University
New York, New York, United States
|
43 |
NCT02584309 |
Recruiting |
Doxorubicin With Upfront Dexrazoxane Plus Olaratumab for the Treatment of Advanced or Metastatic Soft Tissue Sarcoma |
- Sarcoma, Soft Tissue
- Soft Tissue Sarcoma
- Undifferentiated Pleomorphic Sarcoma
- (and 8 more...)
|
- Drug: Dexrazoxane
- Drug: Doxorubicin
- Drug: Olaratumab
|
Interventional |
Phase 2 |
- Washington University School of Medicine
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression-free survival (PFS) (Arm 1 only)
- Cardiac-related mortality
- Incidence of heart failure or cardiomyopathy
- (and 2 more...)
|
75 |
All |
18 Years and older (Adult, Senior) |
NCT02584309 |
201510049 |
|
February 22, 2016 |
October 31, 2023 |
October 31, 2023 |
October 22, 2015 |
February 12, 2018 |
|
- Washington University School of Medicine
Saint Louis, Missouri, United States
|
44 |
NCT02211768 |
Recruiting |
Transformation of Plexiform Neurofibromas to Malignant Peripheral Nerve Sheath Tumors in Neurofibromatosis Type 1 |
|
- Procedure: MRI, FDG-PET/CT scans
- Procedure: [18F]-FLT-PET/CT scans
|
Interventional |
Phase 1 |
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Evaluate the feasibility of wholeexome sequencing and other genetic/genomic methods
- Evaluate the ability of FLT PET to distinguish benign PN from malignant lesions, and to determine if FLT PET is more accurate thanFDG PET in classifying a tumor as benign or malignant
- Determine the feasibility of FLT PET in patients with NF1 and lesionsconcerning for MPNST, or MPNST
|
15 |
All |
10 Years to 99 Years (Child, Adult, Senior) |
NCT02211768 |
140163 14-C-0163 |
|
August 6, 2014 |
July 31, 2019 |
July 31, 2019 |
August 7, 2014 |
March 21, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
45 |
NCT02180867 |
Recruiting |
Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Hydrochloride Before Surgery in Treating Patients With Newly Diagnosed Non-rhabdomyosarcoma Soft Tissue Sarcomas That Can Be Removed by Surgery |
- Adult Fibrosarcoma
- Alveolar Soft Part Sarcoma
- Angiomatoid Fibrous Histiocytoma
- (and 33 more...)
|
- Drug: Doxorubicin Hydrochloride
- Drug: Ifosfamide
- Other: Laboratory Biomarker Analysis
- (and 4 more...)
|
Interventional |
Phase 2 Phase 3 |
- National Cancer Institute (NCI)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Potential benefit for chemoradiotherapy plus pazopanib hydrochloride defined as protocol week 13 pathologic response (Phase II)
- Potential benefit for radiotherapy plus pazopanib hydrochloride defined as protocol week 10 pathologic response (Phase II/III)
- Event-free survival (EFS) (Phase III)
- (and 4 more...)
|
340 |
All |
2 Years and older (Child, Adult, Senior) |
NCT02180867 |
NCI-2014-01340 s14-02023 ARST1321 U10CA180830 U10CA180886 U10CA098543 |
|
July 11, 2014 |
June 13, 2018 |
|
July 3, 2014 |
April 24, 2018 |
|
- Children's Hospital of Alabama
Birmingham, Alabama, United States - The Kirklin Clinic at Acton Road
Birmingham, Alabama, United States - Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States - (and 364 more...)
|
46 |
NCT01532687 |
Recruiting |
Gemcitabine Hydrochloride With or Without Pazopanib Hydrochloride in Treating Patients With Refractory Soft Tissue Sarcoma |
- Adult Alveolar Soft Part Sarcoma
- Adult Angiosarcoma
- Adult Desmoplastic Small Round Cell Tumor
- (and 16 more...)
|
- Drug: Gemcitabine Hydrochloride
- Other: Laboratory Biomarker Analysis
- Drug: Pazopanib Hydrochloride
- Other: Placebo
|
Interventional |
Phase 2 |
- OHSU Knight Cancer Institute
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Progression-free survival (PFS)
- Best overall response rate
- Incidence of adverse events and serious adverse events, defined using the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0.
- (and 3 more...)
|
80 |
All |
18 Years and older (Adult, Senior) |
NCT01532687 |
7943 NCI-2012-00052 P30CA069533 |
|
March 2012 |
March 2019 |
March 2019 |
February 14, 2012 |
November 6, 2017 |
|
- OHSU Knight Cancer Institute
Portland, Oregon, United States
|
47 |
NCT00924196 |
Recruiting |
Natural History Study of Patients With Neurofibromatosis Type I |
- Neurofibromatosis Type 1
- Malignant Peripheral Nerve Sheath Tumor
- Plexiform Neurofibroma
- (and 2 more...)
|
|
Observational |
|
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- To serve as an umbrella protocol for the ongoing NF1 clinical trialsprogram to longitudinally characterize and analyze NF1 related tumor and non-tumor manifestations, and to develop a better understanding of the biology of NF1 related manifes...
|
250 |
All |
up to 100 Years (Child, Adult, Senior) |
NCT00924196 |
080079 08-C-0079 |
|
February 26, 2008 |
|
|
June 18, 2009 |
April 25, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
48 |
NCT03231306 |
Recruiting |
Phase II Study of Binimetinib in Children and Adults With NF1 Plexiform Neurofibromas |
- Neurofibromatosis Type 1
- Plexiform Neurofibroma
|
|
Interventional |
Phase 2 |
- University of Alabama at Birmingham
- Array BioPharma
- Pacific Pediatric Neuro-Oncology Consortium
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change from Baseline Target Tumor Volume at 12 months
- Incidence of Treatment-Emergent Adverse Events
|
20 |
All |
1 Year and older (Child, Adult, Senior) |
NCT03231306 |
IRB-170616001 |
NF108-BINI |
November 28, 2017 |
October 2019 |
December 2023 |
July 27, 2017 |
March 26, 2018 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Children's Hospital of Los Angeles
Los Angeles, California, United States - University of California at Los Angeles
Los Angeles, California, United States - (and 19 more...)
|