NCT04115254NARecruiting

Stereotactic Magnetic Resonance Guided Radiation Therapy

Dana-Farber Cancer Institute

Start Date

10/22/2019

Completion Date

6/1/2028

Summary

This is a master prospective Phase I-II trial evaluating feasibility and efficacy of stereotactic magnetic resonance (MR) guided adaptive radiation therapy (SMART) in patients with cancer. * The phase 1 study will evaluate the feasibility and safety of delivering SMART in patients with cancer. * Phase 2 will evaluate efficacy of SMART with specific reference to tumor control and improvement in patient reported outcome measures

Detailed Description

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 to treat cancer. The U.S. Food and Drug Administration (FDA) has approved this device as a treatment option for cancer. In this research study, the investigators are hoping to determine if adjusting radiation treatments based on daily MRI has a feasible way to deliver radiation for participants with pancreatic, lung or renal cancer.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Participants must have a confirmed malignancy requiring stereotactic body radiation therapy. See specific disease site cohorts for more details. * Tumor size ≤ 7cm * 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. * Specific eligibility requirements for each disease site with be covered in each specific cohort. Exclusion Criteria: * Specific exclusion requirements for each disease site with be covered in each specific cohort * History of allergic reactions attributed to gadolinium-based IV contrast. \-- Note: If a patient will not receive contrast, this is not applicable * Pregnant women are excluded from this study. * Severe claustrophobia or anxiety * Participants who cannot undergo an MRI

Interventions

RADIATION

MR-guided Linac

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Conditions

Pancreas CancerLung CancerRenal CancerAdrenal MetastasesProstate CancerLiver MetastasesOligoprogressive Nodal MetastasesMetachronous Nodal MetastasesSynchronous Nodal MetastasesMesotheliomaSpine MetastasesBrain MetastasesBorderline Resectable Pancreatic Carcinoma

Locations

Brigham & Women's Hospital

Boston, Massachusetts 02115

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02115

United States