Back to resultsTumor Perfusion and Hypoxia Assessed by DCE-MRI and 18F-FMISO PET as Biomarkers of Treatment Response in Cervical Cancer
Primary Purpose
Cervical Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DCE-MRI and 18F-FMISO PET
Sponsored by
About this trial
This is an interventional diagnostic trial for Cervical Cancer focused on measuring DCE-MRI, 18F-FMISO PET, 11-174
Eligibility Criteria
Inclusion Criteria:
- Biopsy-documented, newly-diagnosed primary cervical cancer of all histopathology types.
- Clinically visible gross lesion (International Federation of Gynecology and Obstetrics (FIGO) stage IB1 and above).
- Treatment (chemoradiation), DCE-MRI and 18F-FMISO PET studies will be at MSKCC.
- Patients must be an adult female 18 years of age or older.
Exclusion Criteria:
- Patients who because of general medical or psychiatric condition, or physiologic status cannot give an informed consent.
- Patients who received prior radiation treatment to pelvis.
- Patients with contraindications to DCE-MRI (non-compatible cardiac pacemakers or intracranial vascular clips, allergy to Gadolinium, end-stage renal disease) and/or 18F-FMISO PET.
- Patients who do not fulfill the screening criteria for safe DCE-MRI or 18F-FMISO PET as per the Department of Radiology guidelines.
- Pregnant patients; and or patients who are breast-feeding their babies.
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DCE-MRI and 18F-FMISO PET
Arm Description
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.
Outcomes
Primary Outcome Measures
predict tumor response
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.
Secondary Outcome Measures
predict disease-free survival
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.
Full Information
NCT ID
NCT01613521
First Posted
June 5, 2012
Last Updated
March 12, 2014
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT01613521
Brief Title
Tumor Perfusion and Hypoxia Assessed by DCE-MRI and 18F-FMISO PET as Biomarkers of Treatment Response in Cervical Cancer
Official Title
Tumor Perfusion and Hypoxia Assessed by DCE-MRI and 18F-FMISO PET as Biomarkers of Treatment Response in Cervical Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Terminated
Why Stopped
Lack of accrual
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
5. Study Description
Brief Summary
This study is to assess how patients respond to their treatment for cervical cancer. This research does not involve a specific treatment for the cancer that will be recommended by the doctor and may include radiation therapy and/or chemotherapy. This is a separate research imaging study designed to assess how patients respond to their treatment for cervical cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
DCE-MRI, 18F-FMISO PET, 11-174
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DCE-MRI and 18F-FMISO PET
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
DCE-MRI and 18F-FMISO PET
Intervention Description
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.
Primary Outcome Measure Information:
Title
predict tumor response
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
predict disease-free survival
Description
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.
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Biopsy-documented, newly-diagnosed primary cervical cancer of all histopathology types.
Clinically visible gross lesion (International Federation of Gynecology and Obstetrics (FIGO) stage IB1 and above).
Treatment (chemoradiation), DCE-MRI and 18F-FMISO PET studies will be at MSKCC.
Patients must be an adult female 18 years of age or older.
Exclusion Criteria:
Patients who because of general medical or psychiatric condition, or physiologic status cannot give an informed consent.
Patients who received prior radiation treatment to pelvis.
Patients with contraindications to DCE-MRI (non-compatible cardiac pacemakers or intracranial vascular clips, allergy to Gadolinium, end-stage renal disease) and/or 18F-FMISO PET.
Patients who do not fulfill the screening criteria for safe DCE-MRI or 18F-FMISO PET as per the Department of Radiology guidelines.
Pregnant patients; and or patients who are breast-feeding their babies.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oguz Akin, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org/cancer-care/doctor
Description
Memorial Sloan-Kettering Cancer Center
Learn more about this trial
Tumor Perfusion and Hypoxia Assessed by DCE-MRI and 18F-FMISO PET as Biomarkers of Treatment Response in Cervical Cancer
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