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


Description

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

Trial Eligibility

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 Info

Organization

Dana-Farber Cancer Institute


Primary Outcome

Number of Patients and delivering MR-image guided radiation-Phase I


Outcome Timeframe 5 weeks

NCTID NCT04368702

Phases NA

Primary Purpose TREATMENT

Start Date 2021-05-01

Completion Date 2029-06-18

Enrollment Target 70

Interventions

RADIATION Viewray MRIdian® Linac

Locations Recruiting

Brigham & Women's Hospital

United States, Massachusetts, Boston


Dana Farber Cancer Institute

United States, Massachusetts, Boston


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