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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cervical Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

DCE-MRI and 18F-FMISO PET

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No