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Jump: MR Simulation For Radiation Therapy Master Protocol
NCT04545957 · Brigham and Women's Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Judging MR Simulation Procedures: A Phase I-II Study of the Use of Magnetic Resonance Imaging Simulation in the Planning of Radiation Treatments
About this study
This is a Phase I/II clinical trial. A Phase I clinical trial tests the feasibility and safety of an investigational intervention. "Investigational" means that the process targeting high doses of radiation to the tumor based on MRI is still being studied. This research study is a Feasibility Study, which means it is the first-time investigators at this institution are examining this type of MR-guided dose planning. The U.S. Food and Drug Administration (FDA) has cleared MRI planning for use.
* In Phase I of this study, will prospectively determine the feasibility of using an MRI simulator to plan radiation therapy.
* In Phase II, the efficacy of adjusting RT based on MRI simulation will be explored, either by utilizing an MRI-simulation and synthetic CT to plan treatment or by dose-painting based on functional MRI data
Eligibility criteria
Inclusion Criteria:
* Participants must have a confirmed malignancy requiring radiation therapy.
* Age: 18 years or older
* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
* Ability to understand and the willingness to sign a written informed consent document.
* Disease-specific eligibility criteria will be specified in the appropriate subprotocol.
Exclusion Criteria:
* For MRI involving contrast, history of allergic reactions attributed to gadolinium based IV contrast. Note: If patient will not receive contrast, this is not applicable
* Participants who cannot undergo an MRI
* Disease-specific exclusion criteria will be specified in the appropriate subprotocol
Study design
Enrollment target: 86 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2020-10-14
Estimated completion: 2030-10-22
Last updated: 2025-07-28
Interventions
Device: MRI SimulatorRadiation: Radiation Therapy
Primary outcomes
- • Feasibility of acquiring MRI simulation prior to radiation therapy planning (1 Year)
- • Proportion of patients with QOL decline exceeding 2 x MID (baseline up to 24 months)
Sponsor
Brigham and Women's Hospital · other
Contacts & investigators
ContactRaymond Mak, MD · contact · rmak@partners.org · 617-632-5734
InvestigatorRaymond Mak, MD · principal_investigator, Brigham and Women's Hospital
All locations (2)
Brigham and Women HospitalRecruiting
Boston, Massachusetts, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States