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Optimizing Brachytherapy Application and Delivery With MRI Guidance for Gynecologic Cancer

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ClinicalTrials.gov Identifier: NCT03277469
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : February 1, 2018
Sponsor:
Collaborators:
Friends of Dana-Farber, Dana-Farber Cancer Institute
Kaye Foundation, Brigham and Women's Hospital
Information provided by (Responsible Party):
Larissa Lee, MD, Dana-Farber Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Gynecologic Cancer Device: MRI Radiation: Brachytherapy Device: MRI Tracker Not Applicable

Detailed Description:

This research study is designed to develop new technology using MR imaging to improve the brachytherapy procedure for participants with gynecologic cancer. The brachytherapy procedure will take place in an MRI procedure room within the Advanced Multimodality Image-Guided Operating (AMIGO) suite at Brigham and Women's Hospital. The purpose of the study will be to evaluate whether the use of an MR-tracking device will improve the placement of the brachytherapy catheters. This information will also be used to develop new software for real-time brachytherapy planning by our physics team. The investigators believe that the development of an MR-tracking device will allow them to better place the brachytherapy catheters for radiation treatment and ultimately improve outcomes for patients, including better local tumor control and a lower risk of side effects. The investigators will also evaluate new MRI protocols to better define the tumor at the time of brachytherapy. The brachytherapy treatment planning and delivery will follow standard of care.

In the past, brachytherapy treatment planning and delivery for gynecologic cancer was based on plain-film X-rays, which did not account for the shape of the tumor, the unique anatomy of an individual patient or the response to pelvic radiation therapy. In the last decade, advances in technology have made it possible to perform the brachytherapy procedure and to plan the delivered radiation dose based on CT or MR imaging. The use of CT or MR imaging for brachytherapy planning is increasingly common in the United States, and has been shown to result in improved tumor controls rates and a lower risk of radiation complications. The use of MRI-guidance during the brachytherapy procedure is unique and this study will contribute the advancement of this important technology. About half of the participants in this study will be selected to have the MRI-guided brachytherapy procedure with the use of an MRI-tracking device. This device will provide real-time positioning information of the individual brachytherapy catheters while they are being placed and adjusted within the tumor. The MR-tracker will also be used to develop new software that will allow our physics team to generate a near-instantaneous brachytherapy plan as individual catheters are placed during the procedure. The investigators hope that these advances in technology will have a meaningful impact on further increasing tumor control and limiting the complication risk for our participants.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimizing Brachytherapy Application and Delivery With MRI Guidance for Gynecologic Cancer
Actual Study Start Date : November 13, 2017
Estimated Primary Completion Date : September 15, 2022
Estimated Study Completion Date : September 15, 2027

Arm Intervention/treatment
Experimental: MRI Guided BRACHYTHERAPY with Tracker
  • 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
Medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body

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

Device: MRI Tracker
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.

Experimental: MRI Guided BRACHYTHERAPY without Tracker
  • 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
Medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body

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




Primary Outcome Measures :
  1. Brachytherapy treatment parameters, including V150 [ Time Frame: 3 weeks ]
    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


Secondary Outcome Measures :
  1. Local-Failure-Free Survival [ Time Frame: Baseline to 2 years, 5 years ]
    Time from diagnosis or recurrence to time of local failure

  2. Progression Free Survival [ Time Frame: Baseline to 2 years, 5 years ]
    Time from diagnosis or recurrence to time of documented progression or death

  3. Overall Survival [ Time Frame: Baseline to 2 years, 5 years ]
    Time from diagnosis or recurrence to time of death



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03277469


Contacts
Contact: Teresa Cheng, MPH 617-582-8919 Teresa_Cheng@DFCI.HARVARD.EDU

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Teresa Cheng, MPH    617-732-8421    Teresa_Cheng@DFCI.HARVARD.EDU   
Principal Investigator: Larissa J Lee, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Friends of Dana-Farber, Dana-Farber Cancer Institute
Kaye Foundation, Brigham and Women's Hospital
Investigators
Principal Investigator: Larissa J Lee, MD Brigham and Women's Hospital

Responsible Party: Larissa Lee, MD, Associate Professor of Radiation Oncology, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03277469     History of Changes
Other Study ID Numbers: 17-128
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Larissa Lee, MD, Dana-Farber Cancer Institute:
Gynecologic Cancer