Optimizing Brachytherapy Application and Delivery With MRI Guidance for Gynecologic Cancer
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ClinicalTrials.gov Identifier: NCT03277469 |
Recruitment Status :
Active, not recruiting
First Posted : September 11, 2017
Last Update Posted : August 1, 2023
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Tracking Information | |||||||
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First Submitted Date ICMJE | September 7, 2017 | ||||||
First Posted Date ICMJE | September 11, 2017 | ||||||
Last Update Posted Date | August 1, 2023 | ||||||
Actual Study Start Date ICMJE | November 13, 2017 | ||||||
Estimated Primary Completion Date | September 15, 2024 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Optimizing Brachytherapy Application and Delivery With MRI Guidance for Gynecologic Cancer | ||||||
Official Title ICMJE | Optimizing Brachytherapy Application and Delivery With MRI Guidance for Gynecologic Cancer | ||||||
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. | ||||||
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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Gynecologic Cancer | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE |
49 | ||||||
Original Estimated Enrollment ICMJE |
100 | ||||||
Estimated Study Completion Date ICMJE | September 15, 2027 | ||||||
Estimated Primary Completion Date | September 15, 2024 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03277469 | ||||||
Other Study ID Numbers ICMJE | 17-128 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Martin King, MD, PhD, Dana-Farber Cancer Institute | ||||||
Original Responsible Party | Larissa Lee, MD, Dana-Farber Cancer Institute, Associate Professor of Radiation Oncology | ||||||
Current Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Brigham and Women's Hospital | ||||||
Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | ||||||
Verification Date | July 2023 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |