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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
16
Undergo \^18F FMISO PET scan
Undergo \^18F FDG PET scan
Undergo \^18F-FMISO and \^18F FDG PET scan
Undergo \^18 F FMISO PET and \^18F FDG PET
University of Washington Medical Center
Seattle, Washington, United States
Overall Survival (OS)
Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the survival outcome variables.
Time frame: For up to 2 years
Disease-free Survival (DFS)
Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the disease free survival outcome variables.
Time frame: Up to 2 years
Relationship Between Hypoxia-related IHC Biomarkers and Regional FMISO Uptake in Tumor
The value of the biomarker by IHC analyses relates primarily to validating the information content of FMISO images.
Time frame: Up to 2 years
Relationship Between Ki67 and Regional FMISO Uptake in Tumor
The value of the biomarker Ki67 analyses relates primarily to validating the information content of FMISO images.
Time frame: Up to 2 years
Response to XRT Using RECIST
Response for the XRT is evaluated by the radiation oncologists as per standard clinical protocols
Time frame: time to disease progression or 2 years following first FMISO scan
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