Cervical Adenocarcinoma Clinical Trial
Official title:
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
This phase II trial is studying how well PET scans using fluoromisonidazole F 18 and fludeoxyglucose F 18 work in finding oxygen in tumor cells of patients undergoing treatment for newly diagnosed stage 1B, stage II, stage II, or stage IV cervical cancer. Diagnostic procedures using positron emission tomography (PET scan), fluoromisonidazole F 18, and fludeoxyglucose F 18 to find oxygen in tumor cells may help doctors predict how patients will respond to treatment.
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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
receiving radiotherapy.
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.
OUTLINE:
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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