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NCT04545957 | RECRUITING | Prostate Cancer

Jump: MR Simulation For Radiation Therapy Master Protocol
Sponsor:

Dana-Farber Cancer Institute

Information provided by (Responsible Party):

Raymond Mak, MD

Brief 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.

Condition or disease

Prostate Cancer

Recurrent Adenocarcinoma

Liver Cancer

Head and Neck Cancer

Intervention/treatment

MRI Simulator

Radiation Therapy

Phase

NA

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

Study Type : INTERVENTIONAL
Estimated Enrollment : 86 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2020-10-14
Estimated Primary Completion Date : 2024-11-10
Estimated Study Completion Date : 2026-10-22

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Jump: MR Simulation For Radiation Therapy Master Protocol

Location Details

NCT04545957

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How to Participate

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Locations

RECRUITING

United States, Massachusetts

Brigham and Women Hospital

Boston, Massachusetts, United States, 02115

RECRUITING

United States, Massachusetts

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215