Skip to main content
OpenTrials
Completed

NCT Number: NCT01703195

Magnetic Resonance Imaging of Gynecologic Malignancies Involving the Vagina

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vaginal Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Vaginal Diseases Vaginal Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Magnetic Resonance Imaging (MRI)

Procedure

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

Other names: MRI

Diffusion Weighted Magnetic Resonance Imaging (DWMR)

Procedure

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

Other names: DWMR

Primary outcomes

  1. Accuracy of Tumor Involvement Detection

    Time frame: 1 day

    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.

Secondary outcomes

  1. Ability of Diffusion Weighted Magnetic Resonance Imaging (DWMR) to Assess Response to Radiation Therapy

    Time frame: 4 weeks after radiation therapy treatment

    Secondary endpoints include quantitative measurements of discrepancies (or: quantitative measurement of the discrepancy) between DWMR and exam under anesthesia (EUA), agreement and difference between DWMR and other MR sequences (T2, DGE), and the ability of DWMR to assess response to therapy. Summary statistics of results for each modality tabulated. Accuracy, sensitivity, specificity, PPV, and NPV estimated along with corresponding 95% CIs. Quantitative discrepancy measurements summarized using mean, SD, and range. Difference and agreement between DWMR and other MR sequences assessed using the McNemar test and Kappa statistics, respectively.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Oct 10, 2012
Registry last updated
Sep 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.