Tumor Perfusion and Hypoxia Assessed by DCE-MRI and 18F-FMISO PET as Biomarkers of Treatment Response in Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT01613521|
Recruitment Status : Terminated (Lack of accrual)
First Posted : June 7, 2012
Last Update Posted : March 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Other: DCE-MRI and 18F-FMISO PET||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tumor Perfusion and Hypoxia Assessed by DCE-MRI and 18F-FMISO PET as Biomarkers of Treatment Response in Cervical Cancer|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
Experimental: DCE-MRI and 18F-FMISO PET
Each patient will undergo three DCE-MRI (dynamic contrast-enhanced MRI) studies: a baseline DCE-MRI within two weeks before chemoradiation; a second DCE-MRI after the second week of treatment (within a week); and a third DCE-MRI three months after treatment. As a pilot study in 10 patients, we will perform 18F-FMISO PET/CT on the same day of a baseline DCE-MRI before chemoradiation. Treatment decisions will not be based on DCE-MRI and 18F-FMISO PET/CT studies.
Other: DCE-MRI and 18F-FMISO PET
DCE-MRIs: (i) Baseline DCE-MRI within two weeks before chemoradiation; (ii) Second DCE-MRI after the second week of chemoradiation (within a week); (iii) Third DCE-MRI three months after chemoradiation. iii. 18F-FMISO PET: Baseline 18F-FMISO PET within two weeks before chemoradiation (only 10 patients as a pilot study). iv. Clinical Follow-up: (i) Physical examination (every 3 months); (ii) Pap smear or cervical biopsy (every 3 months); (iii) follow-up imaging studies (CT and/or MRI) as per routine clinical follow-up of patients.
- predict tumor response [ Time Frame: 2 years ]For each DCE-MRI parameter, the relative percent change from baseline to the two-week measurement will be calculated. These values will be assessed using ROC curves to evaluate whether they are predictive of tumor response.
- predict disease-free survival [ Time Frame: 2 years ]baseline tumor perfusion parameters are predictive of disease-free survival at 2 years and 5 years, the primary analysis will again be an ROC analysis, but with the ROC curves modified to take into account the censored failure-outcome. We will create time-dependent ROC curves using methods described by Heagerty et al.
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): NCT01613521
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Oguz Akin, MD||Memorial Sloan Kettering Cancer Center|