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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Terminated

Conditions: Cervical Cancer

Treatments: Other: DCE-MRI and 18F-FMISO PET

Study type: Interventional

Funder types: Other

Identifiers

NCT01613521

11-174

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

DCE-MRI and 18F-FMISO PET

Experimental group

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.

Treatment:

Other: DCE-MRI and 18F-FMISO PET