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


Trial ID:NCT04368702

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Protocol #:19-665

877-DF-TRIAL (877-338-7425)

Condition(s):Bladder Cancer, Gastric Cancer, in Situ Breast Cancer, Invasive Breast Cancer, Larynx Cancer, Mantle Cell Lymphoma


Principal Investigator:Mak, Raymond

Site Research Nurse(s):Mann, Eileen, Marie
Spicer, Beverly, A.

Trial 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.

Eligibility Requirements:
- 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

Protocol #: 19-665

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