Recruiting

MR Simulation

Sponsor:

Brigham and Women's Hospital

Code:

NCT04545957

Conditions

Prostate Cancer

Recurrent Adenocarcinoma

Liver Cancer

Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MRI Simulator

Radiation Therapy

Study Details

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.

Conditions

Prostate Cancer

Recurrent Adenocarcinoma

Liver Cancer

Head and Neck Cancer

Study ID

NCT04545957

Start date

Oct 14, 2020

Status verified date

Jul, 2026

Completion date

Oct 22, 2030

Anticipated

Primary completion date

Oct 22, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

86 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: Phase II MR Simulation Protocol: Track A

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

experimental: 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)

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.

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.

Primary outcome measure

  • Feasibility of acquiring MRI simulation prior to radiation therapy planning [ Time Frame: 1 Year ]
  • Proportion of patients with QOL decline exceeding 2 x MID [ Time Frame: baseline up to 24 months ]

Central Contacts and Locations

Central contacts

Raymond Mak, MD

617-632-5734rmak@partners.org

Locations

Brigham and Women Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Raymond Mak, MD

rmak@partners.org

Principal Investigator:

Raymond Mak, MD

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Raymond Mak, MD

rmak@partners.org

Principal Investigator:

Raymond Mak, MD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-07-20.