FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer
|ClinicalTrials.gov Identifier: NCT00559377|
Recruitment Status : Completed
First Posted : November 16, 2007
Results First Posted : June 26, 2015
Last Update Posted : December 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|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||Other: 18F-fluoromisonidazole Radiation: fluorodeoxyglucose F 18 Procedure: positron emission tomography Other: tissue oxygen measurement||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2007|
|Primary Completion Date :||July 2012|
|Study Completion Date :||May 2014|
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
- 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.
- Relationship Between Hypoxia-related IHC Biomarkers and Regional FMISO Uptake in Tumor [ Time Frame: Up to 2 years ]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 ]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 ]Response for the XRT is evaluated by the radiation oncologists as per standard clinical protocols
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559377
|United States, Washington|
|University of Washington Medical Center|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Joseph Rajendran||University of Washington|