Optimizing Brachytherapy Application and Delivery With MRI Guidance for Gynecologic Cancer

NCT03277469 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 17-128
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to develop new tools using magnetic resonance imaging (MRI) that will improve the brachytherapy procedure and treatment for participants with gynecologic cancer.

Conditions

Gynecologic Cancer

Keywords

Gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

• Brachytherapy treatment parameters, including V150

  Comparison of brachytherapy treatment parameters for patients treated with or without use of an MR-tracker. V150 is the tumor volume that receives at least 150% of the prescribed radiation dose and is a measure of radiation dose heterogeneity

  3 weeks

Secondary Outcomes (3)

• Local-Failure-Free Survival

  Baseline to 2 years, 5 years

• Progression Free Survival

  Baseline to 2 years, 5 years

• Overall Survival

  Baseline to 2 years, 5 years

Study Arms (2)

MRI Guided BRACHYTHERAPY with Tracker

EXPERIMENTAL

* Standard pelvic MRI sequences will be obtained * MRI Tracker is used during catheter positioning with serial MR imaging during implant * All patients will undergo 3D-based image acquisition for brachytherapy treatment planning per standard clinical practice * The brachytherapy modality to be used is high-dose-rate brachytherapy using an iridum-192 stepping source

Device: MRI; Radiation: Brachytherapy; Device: MRI Tracker

MRI Guided BRACHYTHERAPY without Tracker

EXPERIMENTAL

* Standard pelvic MRI sequences will be obtained * Standard process is used with serial MR imaging to evaluate catheter position during implant * All patients will undergo 3D-based image acquisition for brachytherapy treatment planning per standard clinical practice * The brachytherapy modality to be used is high-dose-rate brachytherapy using an iridum-192 stepping source

Device: MRI; Radiation: Brachytherapy

Interventions

MRI DEVICE

Medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body

MRI Guided BRACHYTHERAPY with Tracker; MRI Guided BRACHYTHERAPY without Tracker

Brachytherapy RADIATION

Radiation therapy that is delivered by inserting radioactive sources directly into a tumor

MRI Guided BRACHYTHERAPY with Tracker; MRI Guided BRACHYTHERAPY without Tracker

MRI Tracker DEVICE

The MR tracking device consists of a series of radiofrequency (RF) microcoils that are embedded into brachytherapy catheter stylet. The RF microcoils allows for accurate spatial localization of an individual brachytherapy catheter.

MRI Guided BRACHYTHERAPY with Tracker

Eligibility Criteria

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

You may qualify if:

• Ability to understand and the willingness to sign a written informed consent document. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
• Participants must have a biopsy-proven diagnosis of primary or recurrent gynecologic cancer for which intracavitary or interstitial brachytherapy is planned as standard treatment. Eligible disease sites include primary or recurrent cancer of endometrial, ovarian, cervical, vaginal, or vulvar origin.
• Age of 18 years or older are eligible.
• ECOG performance status of 2 or less.
• Patients who have received prior radiation or chemotherapy may be enrolled on this study.
• Participant is deemed to be an appropriate candidate for MRI-guided brachytherapy by the radiation oncologist and the patient elects to be treated with MRI-guided brachytherapy.
• Participant provides informed consent for prospective collection of relevant medical records for analysis of clinical outcome and treatment-planning techniques.

You may not qualify if:

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, interstitial lung disease, active peptic ulcer disease or gastritis, active bleeding diatheses, serious chronic gastrointestinal conditions associated with diarrhea or psychiatric illness/social situations that would limit compliance with study requirements.
• Contraindication to MRI identified by the MR procedure screening form, such as a pacemaker, aneurysm clip, inner ear implant, neurostimulator, or other non-MR compatible implant or device.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: collaborator
• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

Brachytherapy

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Martin King, MD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiation Oncology

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 11, 2017
• Study Start: November 13, 2017
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): September 15, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)