Magnetic Resonance Imaging of Gynecologic Malignancies Involving the Vagina
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 6 extra minutes. It should take about 45
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Accuracy of Tumor Involvement Detection
Location of tumor involvement determined based on pre-treatment imaging findings, where inferior margin of tumor marked on the MRI. Tumor involved areas will then be evaluated by EUA, where fiducial markers will be placed and MRI images will be fused with the CT images to find if there is any discrepancy between the EUA and the DWI images. The primary endpoint is the accuracy of tumor involvement detection (binary endpoint), where tumor invasion is defined as similar to that seen by EUA, in the anterior/posterior or the lateral walls of the vagina. Similarity will be defined as the tumor margin seen on MRI being similar to what is seen on the EUA where the markers correspond to the margins defined on the MRI. This will be defined as 5mm or less.
Priya Bhosale, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
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