Magnetic Resonance Imaging (MRI) Brachytherapy Applicator Study

NCT01706705 | Completed Results

• 2 other identifiers: 2012-0546NCI-2012-02120
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Improved Image Quality in the Shifted Position

  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.

  At the time of implant

Secondary Outcomes (1)

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

  At the time of implant

Other Outcomes (5)

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

  24 months from baseline

• 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".

  24 months from baseline ( 2-years)

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

  24 months from baseline ( 2-years)

Study Arms (1)

Brachytherapy Treatment Planning

EXPERIMENTAL

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; Other: Computed Tomography (CT); Other: Magnetic Resonance Imaging (MRI)

Interventions

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.

Also known as: MDA Applicator

Brachytherapy Treatment Planning

Computed Tomography (CT) OTHER

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

Also known as: CT

Brachytherapy Treatment Planning

Magnetic Resonance Imaging (MRI) OTHER

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

Also known as: MRI

Brachytherapy Treatment Planning

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Dr. Ann Klopp / Associate Professor, Radiation Oncology
• Organization: UT MD Anderson Cancer Center

aklopp@mdanderson.org

713-563-6930

Study Officials

• Ann Klopp, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: October 15, 2012
• Study Start: October 22, 2012
• Primary Completion: April 22, 2018
• Study Completion: April 22, 2018
• Last Updated: February 23, 2022
• Results First Posted: February 23, 2022

Record last verified: 2022-01

Locations

US (1)