Positron Emission Tomography Using Fluoromisonidazole F 18 and Fludeoxyglucose F 18 to Find Oxygen in Tumor Cells of Patients Undergoing Treatment for Newly Diagnosed Stage IB, Stage II, Stage III, or Stage IV 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.
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
Radiation: fludeoxyglucose F 18
Procedure: positron emission tomography
Other: tissue oxygen measurement
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|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|
- Overall survival (OS) [ Time Frame: For up to 2 years ] [ Designated as safety issue: No ]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.
- Disease-free survival (DFS) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Multivariate Cox regression (Kalbfleisch 1980) will be used to analyze DFS.
- Response to radiotherapy as measured by standard Response Evaluation Criteria in Solid Tumors (RECIST) criteria [ Time Frame: Assessed up to 2 years ] [ Designated as safety issue: No ]Response analysis will be approached using multivariate logistic regression (McCullagh 1989). All patients included in the study must be assessed for response to treatment, even if there are major protocol treatment deviations or if they are ineligible.
- Relationship between hypoxia-related biomarkers (HIF1-α and VEGF by immunohistochemistry [IHC]), proliferation biomarkers (microvascular density, p53, and Ki-67 by IHC), and regional fluoromisonidazole F 18 uptake in tumor [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]We will perform ANOVA and Kruskal-Wallis analysis across the different categories to look for significant associations. The value of the biomarker analyses relates primarily to validating the information content of FMISO images.
|Study Start Date:||November 2007|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Experimental: Diagnostic (^18F FMISO PET and ^18F FDG PET)
Patients receive ^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 ^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.
Undergo ^18F FMISO PET scan
Other Name: 18F-FMISORadiation: fludeoxyglucose F 18
Undergo ^18F FDG PET scan
Other Names:Procedure: positron emission tomography
Undergo ^18F-FMISO and ^18F FDG PET scan
Other Names:Other: tissue oxygen measurement
Undergo ^18 F FMISO PET and ^18F FDG PET
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 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559377
|United States, Washington|
|University of Washington Medical Center|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Joseph Rajendran||University of Washington|