An interventional study of Viewray MRIdian® Linac in Gastric Cancer, Invasive Breast Cancer and in Situ Breast Cancer, sponsored by Brigham and Women's Hospital. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
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.
This is a master clinical protocol evaluating magnetic resonance (MR) image guided radiation in patients with gastric and breast cancer.
In this research study, the investigators are researching if getting an MRI during radiation is a feasible way to delivery radiation. In this research study, a MRI done during treatment will help doctors adapt the radiation to target the most precise spot where the cancer is located.
The research study procedures include:
This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of investigational radiation treatment and also tries to define the appropriate dose of the investigational radiation treatment to use for further studies. "Investigational" means that the way the radiation treatment is delivered is 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 radiation. Investigators at other hospitals and academic centers are already using this type of radiation.
The U.S. Food and Drug Administration (FDA) has approved this radiation machine and these drugs as treatment options for gastric and breast cancer.
2,851 studies on the registry are indexed under Stomach Neoplasms; 863 are open to participants now.
This study's planned enrollment of 70 is close to the median of 67 across 2,095 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
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
Radiation: Viewray MRIdian® Linac
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
Radiation: Viewray MRIdian® Linac
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
Radiation: Viewray MRIdian® Linac
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
Radiation: Viewray MRIdian® Linac
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
Radiation: Viewray MRIdian® Linac
MR-image guided radiation will be administered per disease site standards.
Number of Patients and delivering MR-image guided radiation-Phase I
Master feasibility study evaluating MR-image guided radiation. Feasibility is defined as Enrolling patients and delivering MR-image guided radiation on the MR Linac
Time frame: 5 weeks
Tumor Assessment with MR Guidance-Phase I
Master feasibility study evaluating MR-image guided radiation. Feasibility is defined as assessing tumor using MR guidance before, during and after MR-guided treatment patient.
Time frame: 5 weeks
Patient reported outcomes (PROMs) -Phase II
PROMs are collected at patient visits. PROMs will be evaluated using the Patient-Reported Outcomes Measurement Information System (PROMIS). The PROMIS Global-10 metric collects information on symptoms and quality of life.
Time frame: 1 year
1-year tumor control-Phase II
Tumor response 1 year after radiation treatment
Time frame: 1 year
Rate of Pathologic complete response-Gastric
full pathological review of surgical specimen according to the AJCC Staging Classification, 8th edition. pCR will be defined as the absence of any viable tumor cells within the pathologic specimen.
Time frame: 1 year
Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0.
Toxicity of MRgRT with concurrent chemotherapy will be summarized by category and grade according to CTCAE version 5.0.
Time frame: 90 Days
Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0.
CTCAE version 5.0.
Time frame: 1 year
Duration of treatment with goal of >80% of cases treated within 90 minutes
Total time of treatment for each fraction
Time frame: 7 weeks
Number of treatment fractions that would have resulted in unacceptably high dose (exceeding constraint) to an OAR without MR-image guided radiation.
Importance of MR-guidance
Time frame: 5 Weeks
Progression Free Survival
Estimated using the Kaplan Meier method with 95% confidence intervals based on the complementary log-log transformation.
Time frame: irst date of protocol therapy to the earliest date of disease progression per RECIST criteria or death due to any cause up to 12 Months
Overall Survival
The OS rate will be estimated using the Kaplan-Meier method with 95% confidence intervals based on the complementary log-log transformation.
Time frame: irst date of protocol therapy to the date of death due to any cause. OS time will be censored at the date of last follow-up for patients still alive up to 1 year
Characterizing MRI-based tumor alterations/changes following MR-image guided radiation
Evaluation of tumor response following treatment
Time frame: 1 Year
Plan to share: Yes — The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Sap, Icf
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