NCT00559377

FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Adenocarcinoma
• Cervical Squamous Cell Carcinoma
• Stage IB Cervical Cancer
• Stage IIA Cervical Cancer
• Stage IIB Cervical Cancer
• Stage III Cervical Cancer
• Stage IVA Cervical Cancer
• Stage IVB Cervical Cancer

Interventions

Type	Name	Description
OTHER	18F-fluoromisonidazole	Undergo \^18F FMISO PET scan
RADIATION	fluorodeoxyglucose F 18	Undergo \^18F FDG PET scan
PROCEDURE	positron emission tomography	Undergo \^18F-FMISO and \^18F FDG PET scan
OTHER	tissue oxygen measurement	Undergo \^18 F FMISO PET and \^18F FDG PET

Timeline

• Start date: 2007-11-01
• Primary completion: 2012-07-01
• Completion: 2014-05-01
• First posted: 2007-11-16
• Last updated: 2016-12-30
• Results posted: 2015-06-26

Locations

1 site across 1 country: United States