Magnetic Resonance Imaging (MRI) Brachytherapy Applicator Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Device: Intracavitary Applicator Placement
* Other: Computed Tomography (CT)
* Other: Magnetic Resonance Imaging (MRI)


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brachytherapy Treatment Planning<br>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<br>* 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.<br>* Other names: MDA Applicator;Other: Computed Tomography (CT)<br>* CT scan performed after implant is placed in operating room. CT scan should take about 20 minutes.<br>* Other names: CT;Other: Magnetic Resonance Imaging (MRI)<br>* MRI scan performed after implant is placed in the operating room. MRI should take about 45 minutes.<br>* Other names: MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Improved Image Quality in the Shifted Position | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CT, Cervical Cancer, Radiation therapy, XRT, External beam therapy, Brachytherapy, Intracavitary brachytherapy, ICBT, MRI compatible intracavitary applicators, Computed tomography, Magnetic resonance imaging, MRI, MRI compatible applicators, 3D image guided treatment planning, 2D treatment planning