Magnetic Resonance Imaging of Gynecologic Malignancies Involving the Vagina

NCT01703195 | Completed

• 2 other identifiers: 2011-0656NCI-2012-02054
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Secondary Outcomes (1)

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

  4 weeks after radiation therapy treatment

Study Arms (1)

Diffusion Weighted Magnetic Resonance Imaging (DWMR)

OTHER

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

Procedure: Magnetic Resonance Imaging (MRI); Procedure: Diffusion Weighted Magnetic Resonance Imaging (DWMR)

Interventions

Magnetic Resonance Imaging (MRI) PROCEDURE

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

Also known as: MRI

Diffusion Weighted Magnetic Resonance Imaging (DWMR)

Diffusion Weighted Magnetic Resonance Imaging (DWMR) PROCEDURE

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

Also known as: DWMR

Diffusion Weighted Magnetic Resonance Imaging (DWMR)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Vaginal Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Priya Bhosale, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2012
• First Posted: October 10, 2012
• Study Start: November 1, 2012
• Primary Completion: September 19, 2019
• Study Completion: September 19, 2019
• Last Updated: September 23, 2019

Record last verified: 2019-09

Locations

US (1)