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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Cervical Adenocarcinoma
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Overall Survival (OS)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed squamous cell or adenocarcinoma of the uterine cervix
- •Clinical stage IB-IVB by FIGO criteria
- •Size of the primary tumor ≥ 2 cm as assessed by CT scan
- •Measurable disease
- •Scheduled to undergo radiotherapy, chemotherapy, or combined multimodality management
- •No prior cervical cancer diagnosis
- •No known brain metastases
- •ECOG performance status (PS) 0-2 (Karnofsky PS 60-100%)
- •Life expectancy \> 12 months
- •Not pregnant
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Overall Survival (OS)
Time Frame: For up to 2 years
Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the survival outcome variables.
Disease-free Survival (DFS)
Time Frame: Up to 2 years
Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the disease free survival outcome variables.
Secondary Outcomes
- Relationship Between Hypoxia-related IHC Biomarkers and Regional FMISO Uptake in Tumor(Up to 2 years)
- Relationship Between Ki67 and Regional FMISO Uptake in Tumor(Up to 2 years)
- Response to XRT Using RECIST(time to disease progression or 2 years following first FMISO scan)