A Phase 2 Study of Positron Emission Tomography Imaging With [18F]-Fluoromisonidazole (FMISO) and [18F]-Fluorodeoxyglucose (FDG) for Assessment of Tumor Hypoxia in Cervical Cancer
I. Test the extent to which fluoromisonidazole F 18 ([^18F] FMISO) uptake predicts survival
of patients undergoing therapy for newly diagnosed stage IB-IVB cervical cancer.
I. Test [^18F] FMISO tumor uptake as an independent predictor of response to therapy and
that it provides additional predictive power over fludeoxyglucose F 18 ([^18F] FDG).
II. Test [^18F] FMISO tumor uptake as a predictor of response in a subgroup of patients
III. Test the relationship between [^18F] FMISO uptake in the primary tumor and the volume
of the primary tumor estimated by CT scan.
IV. Test the reproducibility of [^18F] FMISO uptake in tumors by imaging the same patients
on sequential days in a test-retest protocol.
V. Compare [^18F] FMISO PET or PET/CT scan with [^18F] FDG PET or PET/CT scan to test
whether [^18F] FMISO is an independent predictor of treatment outcome.
Patients receive fluoromisonidazole F 18 ([^18F] FMISO) IV over 1 minute followed by PET
scanning. Patients undergo a second [^18F] FMISO PET scan 4-8 weeks later. Patients who have
not had a prior fludeoxyglucose F 18 ([^18F] FDG) PET scan as part of their routine clinical
management undergo [^18F] FDG PET scanning at baseline. A subset of 10 patients undergo two
[^18F] FMISO PET scans within a 48-hour period to evaluate the variability (test-retest) of
this imaging measurement.
Patients response to therapy is followed periodically until time to disease progression or
for 2 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Overall survival (OS)
The first analysis will evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the survival outcome variables. Multivariate Cox regression (Kalbfleisch 1980) will be used to analyze OS.
For up to 2 years
University of Washington
United States: Food and Drug Administration
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