Magnetic Resonance Imaging of Gynecologic Malignancies Involving the Vagina
Primary Purpose
Vaginal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnetic Resonance Imaging (MRI)
Diffusion Weighted Magnetic Resonance Imaging (DWMR)
Sponsored by
About this trial
This is an interventional diagnostic trial for Vaginal Cancer focused on measuring 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
Eligibility Criteria
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)
Sites / Locations
- University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Diffusion Weighted Magnetic Resonance Imaging (DWMR)
Arm Description
Patients receive Magnetic Resonance Imaging (MRI) and Diffusion Weighted Magnetic Resonance Imaging (DWMR) imaging pre-treatment and 4-6 weeks post-treatment.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Ability of Diffusion Weighted Magnetic Resonance Imaging (DWMR) to Assess Response to Radiation Therapy
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.
Full Information
NCT ID
NCT01703195
First Posted
October 5, 2012
Last Updated
September 20, 2019
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT01703195
Brief Title
Magnetic Resonance Imaging of Gynecologic Malignancies Involving the Vagina
Official Title
Magnetic Resonance Imaging of Gynecologic Malignancies Involving the Vagina
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
September 19, 2019 (Actual)
Study Completion Date
September 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diffusion Weighted Magnetic Resonance Imaging (DWMR)
Arm Type
Other
Arm Description
Patients receive Magnetic Resonance Imaging (MRI) and Diffusion Weighted Magnetic Resonance Imaging (DWMR) imaging pre-treatment and 4-6 weeks post-treatment.
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging (MRI)
Other Intervention Name(s)
MRI
Intervention Description
Magnetic Resonance Imaging (MRI) obtained pre-treatment and 4-6 weeks post-treatment.
Intervention Type
Procedure
Intervention Name(s)
Diffusion Weighted Magnetic Resonance Imaging (DWMR)
Other Intervention Name(s)
DWMR
Intervention Description
Diffusion Weighted Magnetic Resonance Imaging (DWMR) obtained pre-treatment and 4-6 weeks post-treatment.
Primary Outcome Measure Information:
Title
Accuracy of Tumor Involvement Detection
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Ability of Diffusion Weighted Magnetic Resonance Imaging (DWMR) to Assess Response to Radiation Therapy
Description
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.
Time Frame
4 weeks after radiation therapy treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priya Bhosale, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website
Learn more about this trial
Magnetic Resonance Imaging of Gynecologic Malignancies Involving the Vagina
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