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Completed

NCT Number: NCT01706705

Magnetic Resonance Imaging (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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with stage greater than or equal to IB2 cervical cancer treated with definitive chemoradiation or radiation therapy who require intracavitary brachytherapy.

Exclusion criteria

  • Patient or tumor anatomy that requires use of a non-MRI-compatible applicator.
  • Patients who require interstitial brachytherapy.
  • Patients whose treating physician feels that they require additional 3D imaging at the time of implant based on physical exam or initial findings.
  • Patients with implantable cardioverter-defibrillator, pacemaker or other implanted device, which precludes MRI acquisition.

Treatment and study plan

Intracavitary Applicator Placement

Device

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 names: MDA Applicator

Computed Tomography (CT)

Other

CT scan performed after implant is placed in operating room. CT scan should take about 20 minutes.

Other names: CT

magnetic resonance imaging (MRI)

Other

MRI scan performed after implant is placed in the operating room. MRI should take about 45 minutes.

Other names: MRI

Primary outcomes

  1. Number of Participants With Improved Image Quality in the Shifted Position

    Time frame: At the time of implant

    To determine the number of participants with improved image quality using the Novel Brachytherapy Applicator, using subjective and objective measures. In the subjective, for assessment of image quality for clinical use, the images obtained in the "shifted" position and in the "standard" position, were compared by a radiation oncologist without knowledge of which was the first and which was the second image. To provide and objective measure of the reduction in image artifact with the shields shifted, the bladder, rectum, and sigmoid were contoured, and average and standard deviation of Hounsfield units (HU) within these critical structures on the images were compared.

Secondary outcomes

  1. Number of Participants With High Quality Images With the Adaptive Applicator in the Shifted or Standard Position

    Time frame: At the time of implant

    The number of participants with high quality images of the bladder, rectum and sigmoid with the adaptive applicator in the shifted position and standard position assessed by the Hounsfield unit values. The higher quality images are the images with higher density when the applicator is in either the shifted or standard position. The Hounsfield unit (HU) is a relative quantitative measurement of radio density used by radiologists in the interpretation of computed tomography (CT) images. The images obtained in the "shifted" position and in the "standard" position with the use of the adaptive applicator, were compared by a radiation oncologist without knowledge of which was the first and which was the second image.

Other outcomes

  1. 3D Image-guided Intracavitary Brachytherapy Treatment Planning in Cervical Cancer

    Time frame: 24 months from baseline

    Analysis was conducted using JMP Pro statistical software for patients diagnosis of 1B2cervical cancer

  2. 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".

    Time frame: 24 months from baseline ( 2-years)

    Utility of MRI imaging as compared to CT or MRI can improve dosimetric tumor coverage and normal tissue sparing.

  3. Clinical and Tumor Characteristics of Patients in Whom CT or MRI Can Improve Dosimetric Tumor Coverage and Normal Tissue Sparing

    Time frame: 24 months from baseline ( 2-years)

    MRI-based brachytherapy planning for patients with tumors >5 cm and parametrial invasion on MRI at diagnosis and for those with a high BMI

  4. Feasibility of MRI-based Treatment Planning Utilizing the Shielded MD Anderson Adaptive Applicator.

    Time frame: 24 months from baseline ( 2-years)

    RI-adaptive applicators for treatment planning for every case/patient.

  5. Relative Resource Utilization for MRI and CT Based Treatment Planning as Compared to Standard Film Based Planning Techniques.

    Time frame: Not able to complete

    Due to lack of a suitable comparison population during this timeframe- at our institution, these protocol-eligible cervical cancer patients were no longer undergoing brachytherapy treatment planning based solely off standard plain films alone.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Oct 15, 2012
Registry last updated
Feb 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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