Magnetic Resonance Imaging (MRI) Brachytherapy Applicator Study

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01706705
Study type	Interventional
Source	M.D. Anderson Cancer Center
Contact
Status	Completed
Phase	N/A
Start date	October 22, 2012
Completion date	April 22, 2018

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.