Tumor Perfusion and Hypoxia Assessed by DCE-MRI and 18F-FMISO PET as Biomarkers of Treatment Response in Cervical Cancer

Not Applicable

Terminated

• Conditions: Cervical Cancer
• Interventions: Other: DCE-MRI and 18F-FMISO PET

• Registration Number: NCT01613521
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-05
• Study First Submitted QC: 2012-06-05
• Study First Posted: 2012-06-07
• Status Verified: 2014-03
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2014-03-12
• Last Update Posted: 2014-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DCE-MRI and 18F-FMISO PET	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.

Primary Outcome Measures

Name	Time	Method
predict tumor response	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.

Secondary Outcome Measures

Name	Time	Method
predict disease-free survival	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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States