MRI Brachytherapy Applicator Study
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.
Device: Intracavitary Applicator Placement
Other: Computed Tomography (CT)
Other: Magnetic Resonance Imaging (MRI)
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||3D Image-guided Intracavitary Brachytherapy Treatment Planning for Cervical Cancer Using a Novel Shielded Applicator|
- Comparison of 3D Image Guided Treatment Planning to 2D Treatment Planning for Brachytherapy [ Time Frame: 1 day ] [ Designated as safety issue: No ]The goal is to determine if 3D image guided treatment planning allows for improved tumor coverage while respecting normal tissue constraints as compared to standard 2D treatment planning. To address this, the D90 (or the dose to 90% of the HR-CTV volume) and maximally irradiated 2 cc of the bladder (D2 cc bladder) and rectum (D2 cc rectum) will be compared. The quality of the brachytherapy treatment plans will be determined according to dosimetric parameters for the target volumes as well as organs at risk.
|Study Start Date:||October 2012|
|Estimated Primary Completion Date:||October 2017 (Final data collection date for primary outcome measure)|
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 Name: MDA ApplicatorOther: Computed Tomography (CT)
CT scan performed after implant is placed in operating room. CT scan should take about 20 minutes.
Other Name: CTOther: Magnetic Resonance Imaging (MRI)
MRI scan performed after implant is placed in the operating room. MRI should take about 45 minutes.
Other Name: MRI
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706705
|Contact: Ann Klopp, MD||713-563-6930|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ann Klopp, MD||UT MD Anderson Cancer Center|