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|
|Actual Primary Completion Date :||July 2012|
|Actual 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-FMISO
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|