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AutoLITT™ FIM Trial - A Prospective First-In-Man (FIM) Safety Trial of the AutoLITT Laser Treatment of Recurrent/Progressive Brain Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Brain Tumor, Brain Tumor, Recurrent, Brain Neoplasm, Brain Cancer, Glioblastoma Multiforme, Recurrent Glioblastoma Multiforme

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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