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


N/A
18 Years
N/A
Open (Enrolling)
Female
Cervical Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Comparison of 3D Image Guided Treatment Planning to 2D Treatment Planning for Brachytherapy

Outcome Description:

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.

Outcome Time Frame:

1 day

Safety Issue:

No

Principal Investigator

Ann Klopp, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2012-0546

NCT ID:

NCT01706705

Start Date:

October 2012

Completion Date:

Related Keywords:

  • Cervical Cancer
  • 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
  • Uterine Cervical Neoplasms

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030