FDG and FMISO PET Hypoxia Evaluation 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.
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: fluorodeoxyglucose 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 ]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 ] [ Designated as safety issue: No ]Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the disease free survival outcome variables.
- Relationship Between Hypoxia-related IHC Biomarkers and Regional FMISO Uptake in Tumor [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]The value of the biomarker by IHC analyses relates primarily to validating the information content of FMISO images.
- Relationship Between Ki67 and Regional FMISO Uptake in Tumor [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]The value of the biomarker Ki67 analyses relates primarily to validating the information content of FMISO images.
- Response to XRT Using RECIST [ Time Frame: time to disease progression or 2 years following first FMISO scan ] [ Designated as safety issue: No ]Response for the XRT is evaluated by the radiation oncologists as per standard clinical protocols
|Study Start Date:||November 2007|
|Study Completion Date:||May 2014|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Experimental: Diagnostic FMISO AND 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.
Undergo ^18F FMISO PET scan
Other Name: 18F-FMISORadiation: fluorodeoxyglucose 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|