Magnetic Resonance Imaging of Gynecologic Malignancies Involving the Vagina

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

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2019-09-19

Brief Summary

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The goal of this clinical research study is to learn if a type of MRI scan called diffusion weighted imaging (DWI) is accurate in checking the status of tumors. Researchers also want to learn if DWI can predict how tumors will respond to radiation therapy.

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Detailed Description

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If you agree to take part in this study, information will be collected from your medical record including your age, sex, and status of the disease.

For the MRI scans, you will receive a routine contrast drug by vein. Contrast drugs are used by doctors in order to see MRI images more clearly.

A modified MRI scan will performed right after your scheduled standard-of-care MRI scan. This modified MRI scan is the investigational scan. To complete the modified MRI scan, you will need to stay in the MRI scanner for about 8 extra minutes. It should take about 47 minutes total to complete both scans.

The way that researchers program the MRI machine and the order in which the images are taken is what is being modified for the investigational scan. These changes may help researchers capture better images.

Length of Study:

Your participation on this study will be over after the modified MRI scan is complete.

This is an investigational study. The standard-of-care MRI scan method is FDA approved and commercially available for the diagnosis of several diseases. The modified MRI scan method is being used in research only.

Up to 25 participants will be enrolled in this study. All will take part at MD Anderson.

Conditions

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Vaginal 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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Diffusion Weighted Magnetic Resonance Imaging (DWMR)

Patients receive Magnetic Resonance Imaging (MRI) and Diffusion Weighted Magnetic Resonance Imaging (DWMR) imaging pre-treatment and 4-6 weeks post-treatment.

Group Type OTHER

Magnetic Resonance Imaging (MRI)

Intervention Type PROCEDURE

Magnetic Resonance Imaging (MRI) obtained pre-treatment and 4-6 weeks post-treatment.

Diffusion Weighted Magnetic Resonance Imaging (DWMR)

Intervention Type PROCEDURE

Diffusion Weighted Magnetic Resonance Imaging (DWMR) obtained pre-treatment and 4-6 weeks post-treatment.

Interventions

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Magnetic Resonance Imaging (MRI)

Magnetic Resonance Imaging (MRI) obtained pre-treatment and 4-6 weeks post-treatment.

Intervention Type PROCEDURE

Diffusion Weighted Magnetic Resonance Imaging (DWMR)

Diffusion Weighted Magnetic Resonance Imaging (DWMR) obtained pre-treatment and 4-6 weeks post-treatment.

Intervention Type PROCEDURE

Other Intervention Names

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MRI DWMR

Eligibility Criteria

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Inclusion Criteria

1. All patients who have gynecologic malignancies involving the middle third and the distal third of the vagina who will be receiving radiation therapy
2. Patients who have gynecologic malignancies involving the upper, middle and/or lower third of the vagina or are undergoing pelvic exenteration.