Clinical trial NCT01706705: Magnetic Resonance Imaging (MRI) Brachytherapy Applicator Study
Official title: 3D Image-guided Intracavitary Brachytherapy Treatment Planning for Cervical Cancer Using a Novel Shielded Applicator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: Cervical Cancer
Radiation therapy
XRT
External beam therapy
Brachytherapy
Intracavitary brachytherapy
ICBT
MRI compatible intracavitary applicators
Computed tomography
CT
Magnetic resonance imaging
MRI
MRI compatible applicators
3D image guided treatment planning
2D treatment planning
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2012-10-15
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Improved Image Quality in the Shifted Position
timeFrame: At the time of implant
Secondary outcomes:
measure: Number of Participants With High Quality Images With the Adaptive Applicator in the Shifted or Standard Position
timeFrame: At the time of implant
Other outcomes:
measure: 3D Image-guided Intracavitary Brachytherapy Treatment Planning in Cervical Cancer
timeFrame: 24 months from baseline
measure: 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".
timeFrame: 24 months from baseline ( 2-years)
measure: Clinical and Tumor Characteristics of Patients in Whom CT or MRI Can Improve Dosimetric Tumor Coverage and Normal Tissue Sparing
timeFrame: 24 months from baseline ( 2-years)
measure: Feasibility of MRI-based Treatment Planning Utilizing the Shielded MD Anderson Adaptive Applicator.
timeFrame: 24 months from baseline ( 2-years)
measure: Relative Resource Utilization for MRI and CT Based Treatment Planning as Compared to Standard Film Based Planning Techniques.
timeFrame: Not able to complete
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ann Klopp, MD
role: PRINCIPAL_INVESTIGATOR
References: