FET-PET for Evaluation of Response of Recurrent GBM to Avastin

• Status: Completed
• Trial end date: 2015-09-13
• Target enrollment: 0
• Participant gender: All

Summary

Hypothesis: The central hypothesis underlying the proposed research study is that FET-PET will predict durable benefit in patients receiving anti-angiogenic benefit for presumed recurrent GBM (i.e. progression-free survival and overall survival). We have defined one primary specific aim, for which we expect to obtain definitive results, and two secondary aims, under which we plan to generate preliminary data to support a future, larger project.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marcelo F. Di Carli, MD, FACC
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• 1. GBM patients with changes on MRI suggestive of recurrence who have not yet initiated antiangiogenic therapy. 2. Age ≥ 18 3. Anticipated survival >3 months 4. Able to give informed consent 5. Capable of undergoing scan without the need for sedation or general anesthesia.

Exclusion Criteria:

1. Active intracranial infection or nonglial brain mass.

2. Recent large intracranial hemorrhage (<1 month; size to be determined by principal investigator)

3. Pregnant or nursing. Quantitative serum hCG testing will be performed prior to the initial and each -subsequent FET- PET scan on all females of childbearing potential. Our BWH Radiation Safety Committee and Partners IRB requires stat serum ß-hcG pregnancy tests.

4. Patient lives too far from BWH and/or is unwilling/ unable to return for scheduled imaging visits.

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