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NCT04545957NARecruiting

Jump: MR Simulation For Radiation Therapy Master Protocol

Brigham and Women's Hospital

Start Date

10/14/2020

Completion Date

10/22/2030

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.

Detailed Description

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

Age Range: 18 years to No maximum

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

Interventions

DEVICE

MRI Simulator

RADIATION

Radiation Therapy

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Conditions

Prostate CancerRecurrent AdenocarcinomaLiver CancerHead and Neck Cancer

Locations

Brigham and Women Hospital

Boston, Massachusetts 02115

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215

United States