Trial Information
AutoLITT™ FIM Trial - A Prospective First-In-Man (FIM) Safety Trial of the AutoLITT Laser Treatment of Recurrent/Progressive Brain Tumors
Inclusion Criteria:
- Previous diagnosis of GBM treated with radiotherapy with or without surgical
resection and/or chemotherapy
- Clinical/radiographic suspicion of tumor recurrence/progression
Exclusion Criteria:
- Previous treatment of target GBM with stereotactic radiosurgery, brachytherapy, or
carmustine impregnated wafers (Gliadel).
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Primary endpoint is safety, as determined by absence of severe clinical toxicity or procedure-related neurological deficits
Outcome Time Frame:
14 days post-surgery
Safety Issue:
Yes
Principal Investigator
Gene Barnett, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Cleveland Clinic
Authority:
United States: Food and Drug Administration
Study ID:
AutoLITT™ FIM
NCT ID:
NCT00747253
Start Date:
August 2008
Completion Date:
April 2010
Related Keywords:
- Brain Tumor
- Brain Tumor, Recurrent
- Brain Neoplasm
- Brain Cancer
- Glioblastoma Multiforme
- Recurrent Glioblastoma Multiforme
- laser interstitial thermal therapy
- laser therapy
- thermal therapy
- brain tumors
- recurrent brain tumor
- progressive brain tumor
- glioblastoma multiforme tumor
- Brain Neoplasms
- Neoplasms
- Glioblastoma
Name | Location |
Cleveland Clinic Foundation, 9500 Euclid Ave |
Cleveland, Ohio 44195 |
University Hospitals Case Medical Center, 11100 Euclid Ave |
Cleveland, Ohio 44106 |