Recruiting

MRGRT

Sponsor:

Brigham and Women's Hospital

Code:

NCT04368702

Conditions

Gastric Cancer

Invasive Breast Cancer

in Situ Breast Cancer

Mantle Cell Lymphoma

Larynx Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Viewray MRIdian® Linac

Study Details

Brief summary:

This research is being done to determine the safety and feasibility of using a type of radiation guided by magnetic resonance imaging (MRI) and chemotherapy to treat patients with gastric and breast cancer. The name of the radiation machine involved in this study is the MRIdian Linear Accelerator.

Conditions

Gastric Cancer

Invasive Breast Cancer

in Situ Breast Cancer

Mantle Cell Lymphoma

Larynx Cancer

Study ID

NCT04368702

Start date

May 1, 2021

Status verified date

Jan, 2026

Completion date

Jun 18, 2029

Anticipated

Primary completion date

Jun 18, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants must have histologically or cytologically confirmed malignancy requiring radiation
  • Age 18 years of older
  • ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
  • Ability to understand and the willingness to sign a written informed consent document.
  • Any further criteria listed in the specific disease site cohort

Exclusion Criteria

  • History of allergic reactions attributed to gadolinium-based IV contrast

\-- Note: If patient will not receive contrast, this is not applicable and kidney function will not affect eligibility
  • Severe claustrophobia or anxiety
  • Participants who cannot undergo an MRI
  • Any other exclusion criteria listed in the specific disease site cohort

Study Design

Enrollment

70 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase I - Gastric Cancer

The research study procedures include:

  • Screening for eligibility
  • Study treatment including evaluations
  • MR-image guided radiation will be administered per disease site standards.
  • Follow up visits
  • Questionnaires

experimental: Phase I - Breast Cancer

The research study procedures include:

  • Screening for eligibility
  • Study treatment including evaluations
  • MR-image guided radiation will be administered per disease site standards.
  • Follow up visits
  • Questionnaires

experimental: Phase I - Mantle Cell Lymphoma

The research study procedures include:

  • Screening for eligibility
  • Study treatment including evaluations
  • MR-image guided radiation will be administered per disease site standards.
  • Follow up visits
  • Questionnaires

experimental: Phase I - Larynx

The research study procedures include:

  • Screening for eligibility
  • Study treatment including evaluations
  • MR-image guided radiation will be administered per disease site standards.
  • Follow up visits
  • Questionnaires

experimental: Phase I - Bladder

The research study procedures include:

  • Screening for eligibility
  • Study treatment including evaluations
  • MR-image guided radiation will be administered per disease site standards.
  • Follow up visits
  • Questionnaires

Interventions

Viewray MRIdian® Linac

MR-image guided radiation will be administered per disease site standards.

Primary outcome measure

  • Number of Patients and delivering MR-image guided radiation-Phase I [ Time Frame: 5 weeks ]
  • Tumor Assessment with MR Guidance-Phase I [ Time Frame: 5 weeks ]
  • Patient reported outcomes (PROMs) -Phase II [ Time Frame: 1 year ]
  • 1-year tumor control-Phase II [ Time Frame: 1 year ]
  • Rate of Pathologic complete response-Gastric [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Raymond Mak, MD

6177328651rmak@partners.org

Locations

Brigham & Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator:

Raymond Mak, MD

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator:

Raymond Mak, MD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Feb 9, 2026

Last verified

Jan, 2026

Keywords

  • Gastric Cancer
  • Invasive Breast Cancer
  • in Situ Breast Cancer
  • Lymphoma
  • Larynx
  • Bladder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-02-09.