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Trial record 2 of 8 for:    monteris

Feasibility Study on LITT for Newly Diagnosed Glioblastoma (FLAG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02880410
Recruitment Status : Recruiting
First Posted : August 26, 2016
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Monteris Medical

Brief Summary:
Multicenter, open-label, prospective designed study to characterize the performance of brain laser interstitial thermal therapy (LITT) ablation using the Monteris NeuroBlate System in combination with standard of care radiation therapy and temozolomide for the treatment of newly diagnosed glioblastomas (GBM).

Condition or disease Intervention/treatment Phase
Glioblastoma Device: NeuroBlate System Drug: Radiation therapy and temozolomide Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study on Laser Interstitial Thermal Therapy Ablation for the Treatment of Newly Diagnosed Glioblastoma
Actual Study Start Date : August 15, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: LITT Treatment w/radiation therapy and temozolomide
This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System in combination with radiation therapy and temozolomide
Device: NeuroBlate System
Laser Interstitial Thermal Therapy
Drug: Radiation therapy and temozolomide
Radiation therapy and temozolomide



Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 2 Years ]
    Characterize adverse events experienced in glioblastoma subjects undergoing LITT using the NeuroBlate System. Adverse events will be collected based on subject reports and subject examination/testing.


Secondary Outcome Measures :
  1. Progression-Free Survival Rate [ Time Frame: 2 Years ]
    To describe progression-free survival rate in subjects with newly diagnosed glioblastomas treated with the NeuroBlate System

  2. Overall Survival [ Time Frame: 2 Years ]
    To describe/estimate the overall survival of subjects with newly diagnosed glioblastomas treated with LITT using the NeuroBlate System

  3. Changes in Quality of Life [ Time Frame: 2 Years ]
    Characterize the changes in quality of life in subjects with medical temporal lobe epilepsy undergoing LITT using the NeuroBlate System via Quality of Life and neurocognitive assessment tools



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Relevant Inclusion Criteria:

  1. Biopsy proven supratentorial GBM that has not undergone previous surgical resection, radiation and/or chemotherapy
  2. Single enhancing lesion that is >1 cm, but < 4 cm in cross-sectional dimension, including thalamic tumor (≤ 3 cm)
  3. The patient must be ≥18 years of age
  4. KPS > 70
  5. Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder. Patients with prior malignancies must be disease-free for five years.
  6. Stable cardiovascular, pulmonary health status

Relevant Exclusion Criteria:

  1. Seizures occurrence or the requirement of escalation (or addition) of anti-epileptic drugs
  2. Symptoms due to mass effect of the tumor including high intracranial pressure, marked edema or ≥5mm midline shift significant
  3. Uncontrolled cardiovascular conditions of hypertension (systolic >180 mm Hg), angina pectoris, or cardiac dysrhythmia; or recent history of intracranial hemorrhage
  4. Serious infection, immunosuppression or concurrent medical condition (chronic or acute in nature) that may prevent safe participation or ability to meet follow-up requirements
  5. Pregnancy, or planning to become pregnant
  6. Patients whose physical dimensions cannot be accommodated in the MRI scanner or patients with contraindications to MRI imaging such as pacemakers, non-compatible aneurysm clips, shrapnel and other internal ferromagnetic objects
  7. Patients with multiple or multifocal GBM

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880410


Contacts
Contact: Pa Lee (763) 762-2710 plee@monteris.com
Contact: Nissa Mollema (763) 253-4710 ext 2721 nmollema@monteris.com

Locations
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jeanine Portell    314-362-2940    jportell@wustl.edu   
Principal Investigator: Albert Kim, MD         
United States, North Carolina
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Wendy Jenkins    336-716-3842    wejenkin@wakehealth.edu   
Contact: Ashley Carroll Fansler    336-713-3539    arcarrol@wakehealth.edu   
Principal Investigator: Roy Strowd, MD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Teresa Allison    216-444-6459    allisot@ccf.org   
Principal Investigator: Alireza Mohammadi, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Kathy Hunter    713-745-5769    kuhunter@mdanderson.org   
Principal Investigator: Barbara O'Brien         
Sponsors and Collaborators
Monteris Medical
Investigators
Principal Investigator: Manmeet Ahluwalia, MD The Cleveland Clinic

Responsible Party: Monteris Medical
ClinicalTrials.gov Identifier: NCT02880410     History of Changes
Other Study ID Numbers: FLAG
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Monteris Medical:
Glioblastoma
NeuroBlate
LITT
Quality of Life

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents