Magnetic Resonance Imaging of Gynecologic Malignancies Involving the Vagina

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Brief Title

Magnetic Resonance Imaging of Gynecologic Malignancies Involving the Vagina

Official Title

Magnetic Resonance Imaging of Gynecologic Malignancies Involving the Vagina

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.
    


Study Type

Interventional


Primary Outcome

Accuracy of Tumor Involvement Detection

Secondary Outcome

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

Condition

Vaginal Cancer

Intervention

Magnetic Resonance Imaging (MRI)

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

12

Start Date

November 2012

Completion Date

September 19, 2019

Primary Completion Date

September 19, 2019

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)
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Priya Bhosale, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01703195

Organization ID

2011-0656

Secondary IDs

NCI-2012-02054

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center


Study Sponsor

Priya Bhosale, MD, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

September 2019