Clinical trial NCT01703195: Magnetic Resonance Imaging of Gynecologic Malignancies Involving the Vagina
Official title: Magnetic Resonance Imaging of Gynecologic Malignancies Involving the Vagina
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Cancer
Keywords: Vaginal Cancer
Malignancies involving the vagina
Middle third and the distal third of the vagina
Pre and post radiation therapy
Diffusion weighted magnetic resonance imaging
DWMR
Magnetic resonance imaging
MRI
Tumor involvement
Response to radiation therapy
XRT
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2012-10-10
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Exclusion Criteria:

1. Pregnant patients
2. Any implantable medical device that is not MRI compatible (e.g. pacemakers, defibrillators, pain pumps or insulin pumps)

Primary outcomes:
measure: Accuracy of Tumor Involvement Detection
timeFrame: 1 day
Secondary outcomes:
measure: Ability of Diffusion Weighted Magnetic Resonance Imaging (DWMR) to Assess Response to Radiation Therapy
timeFrame: 4 weeks after radiation therapy treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Priya Bhosale, MD
role: PRINCIPAL_INVESTIGATOR
References: