Jump: MR Simulation For Radiation Therapy Master Protocol

NCT ID: NCT04545957

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-14
• Study Completion Date: 2030-10-22

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.

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

Conditions

Prostate Cancer; Recurrent Adenocarcinoma; Liver Cancer; Head and Neck Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase I MRI Simulation

This research study involves a screening period to determine eligibility.

• 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.

Group Type: EXPERIMENTAL

MRI Simulator

Intervention Type: DEVICE

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.

Radiation Therapy

Intervention Type: RADIATION

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.

Phase II MR Simulation Protocol: Track A

MR-only Radiation Therapy Simulation MRI-simulation and synthetic CT to plan treatment

Group Type: EXPERIMENTAL

MRI Simulator

Intervention Type: DEVICE

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.

Radiation Therapy

Intervention Type: RADIATION

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.

Phase II MR Simulation Protocol: Track B

Adjusted Margin or / Dose Painted RT Based on Imaging of MR Simulator (e.g. biological imaging or higher resolution imaging)

Group Type: EXPERIMENTAL

MRI Simulator

Intervention Type: DEVICE

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.

Radiation Therapy

Intervention Type: RADIATION

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.

Interventions

MRI 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.

Intervention Type: DEVICE

Radiation 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.

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Raymond Mak

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raymond Mak, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Raymond Mak, MD

Role: CONTACT

rmak@partners.org

617-632-5734

Facility Contacts

Raymond Mak, MD

Role: primary

rmak@partners.org

Raymond Mak, MD

Role: primary

rmak@partners.org

Other Identifiers

19-759

Identifier Type: -

Identifier Source: org_study_id