Magnetic Resonance Imaging (MRI) Brachytherapy Applicator Study

January 31, 2022 updated by: M.D. Anderson Cancer Center

3D Image-guided Intracavitary Brachytherapy Treatment Planning for Cervical Cancer Using a Novel Shielded Applicator

The goal of this clinical research study is to learn if computed tomography (CT) and magnetic resonance imaging (MRI) images can better help to plan internal radiation treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Treatment planning for patients with cervical cancer treated at MD Anderson is usually performed based on x-ray films taken while the patient is under anesthesia in the operating room. In this study, you will have an MRI and CT scan performed after recovering from anesthesia in addition to the standard x-rays. In order to allow MRI images to be taken, special MRI compatible applicators will be used. The CT and MRI images will be reviewed by the doctor in charge of radiation treatment and will also be used for research purposes.

Study Procedures:

If you agree to take part in this study, an applicator made of a material that can be used during an MRI will be used.

You will have a CT scan and an MRI scan performed after the implant is placed in the operating room. The CT scan should take about 20 minutes and the MRI about 55 minutes. These scans will be performed after you wake up from general anesthesia. Pain medicine will be given if you feel any discomfort from the placement of the implant.

The additional scans will be used to confirm appropriate placement of the applicator and may result in small adjustments to your radiation treatment plan.

Length of Study:

Your active participation on this study will be complete once you have the CT and MRI scans.

Your medical record may be reviewed after the scans for the purposes of the study, but you will not be contacted in the future.

This is an investigational study. The applicator that best fits your personal anatomy will be used in this study. A selection of MRI compatible applicators are available. Many of the MRI applicators that will be used are FDA approved. However, in some cases you may have a novel device with a moveable shield placed. This applicator is not FDA approved or commercially available.

Up to 57 patients will take part in this study. All will be enrolled at MD Anderson.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

1) Women with stage greater than or equal to IB2 cervical cancer treated with definitive chemoradiation or radiation therapy who require intracavitary brachytherapy.

Exclusion Criteria:

  1. Patient or tumor anatomy that requires use of a non-MRI-compatible applicator.
  2. Patients who require interstitial brachytherapy.
  3. Patients whose treating physician feels that they require additional 3D imaging at the time of implant based on physical exam or initial findings.
  4. Patients with implantable cardioverter-defibrillator, pacemaker or other implanted device, which precludes MRI acquisition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brachytherapy Treatment Planning

MRI-compatible intracavitary applicator inserted using ultrasound guidance to verify tandem placement in the uterus. Tandem and ovoids, tandem and cylinders, or tandem and ring chosen to accommodate patient's tumor and vaginal anatomy.

Computed tomography (CT) scan and a magnetic resonance imaging (MRI) scan performed after the implant is placed in the operating room. The CT scan should take about 20 minutes and the MRI about 45 minutes.
Device: Intracavitary Applicator Placement
MRI-compatible applicator inserted using ultrasound guidance to verify tandem placement in the uterus. Tandem and ovoids, tandem and cylinders, or tandem and ring chosen to accommodate patient's tumor and vaginal anatomy.
Other Names:
  • MDA Applicator
Other: Computed Tomography (CT)
CT scan performed after implant is placed in operating room. CT scan should take about 20 minutes.
Other Names:
  • CT
Other: Magnetic Resonance Imaging (MRI)
MRI scan performed after implant is placed in the operating room. MRI should take about 45 minutes.
Other Names:
  • MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Improved Image Quality in the Shifted Position
Time Frame: At the time of implant
To determine the number of participants with improved image quality using the Novel Brachytherapy Applicator, using subjective and objective measures. In the subjective, for assessment of image quality for clinical use, the images obtained in the "shifted" position and in the "standard" position, were compared by a radiation oncologist without knowledge of which was the first and which was the second image. To provide and objective measure of the reduction in image artifact with the shields shifted, the bladder, rectum, and sigmoid were contoured, and average and standard deviation of Hounsfield units (HU) within these critical structures on the images were compared.
At the time of implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With High Quality Images With the Adaptive Applicator in the Shifted or Standard Position
Time Frame: At the time of implant
The number of participants with high quality images of the bladder, rectum and sigmoid with the adaptive applicator in the shifted position and standard position assessed by the Hounsfield unit values. The higher quality images are the images with higher density when the applicator is in either the shifted or standard position. The Hounsfield unit (HU) is a relative quantitative measurement of radio density used by radiologists in the interpretation of computed tomography (CT) images. The images obtained in the "shifted" position and in the "standard" position with the use of the adaptive applicator, were compared by a radiation oncologist without knowledge of which was the first and which was the second image.
At the time of implant

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
3D Image-guided Intracavitary Brachytherapy Treatment Planning in Cervical Cancer
Time Frame: 24 months from baseline
Analysis was conducted using JMP Pro statistical software for patients diagnosis of 1B2cervical cancer
24 months from baseline
Magnetic Resonance Imaging (MRI) is Superior to Computed Tomography (CT) Imaging in Delineating a High Risk Target Volume. 3D Image-guided Intracavitary Brachytherapy Treatment Planning in Cervical Cancer".
Time Frame: 24 months from baseline ( 2-years)
Utility of MRI imaging as compared to CT or MRI can improve dosimetric tumor coverage and normal tissue sparing.
24 months from baseline ( 2-years)
Clinical and Tumor Characteristics of Patients in Whom CT or MRI Can Improve Dosimetric Tumor Coverage and Normal Tissue Sparing
Time Frame: 24 months from baseline ( 2-years)
MRI-based brachytherapy planning for patients with tumors >5 cm and parametrial invasion on MRI at diagnosis and for those with a high BMI
24 months from baseline ( 2-years)
Feasibility of MRI-based Treatment Planning Utilizing the Shielded MD Anderson Adaptive Applicator.
Time Frame: 24 months from baseline ( 2-years)
RI-adaptive applicators for treatment planning for every case/patient.
24 months from baseline ( 2-years)
Relative Resource Utilization for MRI and CT Based Treatment Planning as Compared to Standard Film Based Planning Techniques.
Time Frame: Not able to complete
Due to lack of a suitable comparison population during this timeframe- at our institution, these protocol-eligible cervical cancer patients were no longer undergoing brachytherapy treatment planning based solely off standard plain films alone.
Not able to complete

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Ann Klopp, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2012

Primary Completion (Actual)

April 22, 2018

Study Completion (Actual)

April 22, 2018

Study Registration Dates

First Submitted

October 11, 2012

First Submitted That Met QC Criteria

October 11, 2012

First Posted (Estimate)

October 15, 2012

Study Record Updates

Last Update Posted (Actual)

February 23, 2022

Last Update Submitted That Met QC Criteria

January 31, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-0546
  • NCI-2012-02120 (Registry Identifier: NCI CTRP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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