Jump: MR Simulation For Radiation Therapy Master Protocol (JUMP)

Mass General Brigham

Status

Enrolling

Conditions

Recurrent Adenocarcinoma

Head and Neck Cancer

Liver Cancer

Prostate Cancer

Treatments

Device: MRI Simulator

Radiation: Radiation Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04545957

19-759

Details and patient eligibility

About

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.

Full 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

Enrollment

86 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

86 participants in 3 patient groups

Phase I MRI Simulation

Experimental group

Description:

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.

Treatment:

Radiation: Radiation Therapy

Device: MRI Simulator

Phase II MR Simulation Protocol: Track A

Experimental group

Description:

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

Treatment:

Radiation: Radiation Therapy

Device: MRI Simulator

Phase II MR Simulation Protocol: Track B

Experimental group