RecruitingNot ApplicableNCT04545957

Jump: MR Simulation For Radiation Therapy Master Protocol

Judging MR Simulation Procedures: A Phase I-II Study of the Use of Magnetic Resonance Imaging Simulation in the Planning of Radiation Treatments


Sponsor

Brigham and Women's Hospital

Enrollment

86 participants

Start Date

Oct 14, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This is a master protocol for a prospective Phase I-II study evaluating feasibility and efficacy of incorporating magnetic resonance imaging (MRI) simulation into the planning of radiation treatments.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria2

  • 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

Interventions

DEVICEMRI Simulator

Radiation mapping to define the target for radiation.acquiring MR data at the specified timepoint in a patient's care plan and ability to identify the radiation target and develop a radiation therapy plan on the MR data.

RADIATIONRadiation Therapy

In Phase I, radiation will be institutional standard per disease site. In Phase II, either radiation according to MR-based dose painting or adjusted RT. These adjusted doses and/or RT will vary per disease site and will be pre-specified in the subprotocols.


Locations(2)

Brigham and Women Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

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NCT04545957


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