MRI Brachytherapy Applicator Study

This study is currently recruiting participants.
Verified November 2013 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01706705
First received: October 11, 2012
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Cervical Cancer
Device: Intracavitary Applicator Placement
Other: Computed Tomography (CT)
Other: Magnetic Resonance Imaging (MRI)

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Applicator
Other: Computed Tomography (CT)
CT scan performed after implant is placed in operating room. CT scan should take about 20 minutes.
Other Name: CT
Other: Magnetic Resonance Imaging (MRI)
MRI scan performed after implant is placed in the operating room. MRI should take about 45 minutes.
Other Name: MRI

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 30 patients will take part in this study. All will be enrolled at MD Anderson.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706705

Contacts
Contact: Ann Klopp, MD 713-563-6930

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Ann Klopp, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01706705     History of Changes
Other Study ID Numbers: 2012-0546
Study First Received: October 11, 2012
Last Updated: November 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 15, 2014