Phase 2
Completed N=13
FET-PET for Evaluation of Response of Recurrent GBM to Avastin
Glioblastoma multiforme · GBM
Source: ClinicalTrials.gov NCT01756352 ↗
Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Progression-free Survival — 158.25 days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
158.25 | — |
| SECONDARY Overall Survival |
270.58 | — |
Eligibility 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
- Active intracranial infection or nonglial brain mass.
- Recent large intracranial hemorrhage (<1 month; size to be determined by principal investigator)
- 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.
- Patient lives too far from BWH and/or is unwilling/ unable to return for scheduled imaging visits.
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Data sourced from ClinicalTrials.gov (NCT01756352). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.