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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02880410
Recruitment Status : Terminated (Terminated (failure to enroll))
First Posted : August 26, 2016
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Monteris Medical

Tracking Information
First Submitted Date  ICMJE August 18, 2016
First Posted Date  ICMJE August 26, 2016
Last Update Posted Date August 14, 2019
Actual Study Start Date  ICMJE August 15, 2017
Actual Primary Completion Date September 14, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02880410 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2018)
  • 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
  • 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
  • Changes in Quality of Life [ Time Frame: 2 Years ]
    Characterize the changes in quality of life in subjects with newly diagnosed glioblastoma who are undergoing LITT using the NeuroBlate System via Quality of Life and neurocognitive assessment tools
Original Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2016)
  • 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility Study on LITT for Newly Diagnosed Glioblastoma
Official Title  ICMJE Feasibility Study on Laser Interstitial Thermal Therapy Ablation for the Treatment of Newly Diagnosed Glioblastoma
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE
  • Device: NeuroBlate System
    Laser Interstitial Thermal Therapy
  • Drug: Radiation therapy and temozolomide
    Radiation therapy and temozolomide
Study Arms  ICMJE 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
Interventions:
  • Device: NeuroBlate System
  • Drug: Radiation therapy and temozolomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 12, 2019)
3
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2016)
45
Actual Study Completion Date  ICMJE September 14, 2018
Actual Primary Completion Date September 14, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02880410
Other Study ID Numbers  ICMJE FLAG
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Monteris Medical
Study Sponsor  ICMJE Monteris Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Manmeet Ahluwalia, MD The Cleveland Clinic
Principal Investigator: Sujit Prabhu, MD M.D. Anderson Cancer Center
PRS Account Monteris Medical
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP