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

Memorial Sloan Kettering Cancer Center3 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cervical Cancer

Interventions

DCE-MRI and 18F-FMISO PETOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

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.

Time frame: 2 years

Data from ClinicalTrials.gov

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