Clinical Onboard Utilization of Image Guided Radiation Therapy With Magnetic Resonance (CONFIRM): A Master Protocol


  • Org Study ID: 19-665
  • Secondary ID: N/A
  • NCT ID: NCT04368702
  • Sponsor: Dana-Farber Cancer Institute


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:

* Screening for eligibility
* Study treatment including evaluations
* Follow up visits
* Questionnaires

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.

  • Overall Status
  • Start Date
    May 1, 2021
  • Phase
    Not Applicable
  • Study Type


Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A


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


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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No


Name: Raymond Mak, MD

Role: Principal Investigator

Affiliation: Dana-Farber Cancer Institute

Overall Contact

Name: N/A

Phone: N/A

Email: N/A


Facility Status Contact