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Stereotactic Magnetic Resonance Guided Radiation Therapy

NCT04115254 · Dana-Farber Cancer Institute
In plain English

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Official title
A Master Protocol of Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy (SMART)
About this study
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
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
Study design
Enrollment target: 397 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2019-10-22
Estimated completion: 2028-06
Last updated: 2025-11-13
Interventions
Radiation: MR-guided Linac
Primary outcomes
  • Delivery Success Rate for SMART across multiple tumors-Phase I (1 year)
  • Tumor visualization-Phase I (1 Year)
  • Plan creation-Phase I (1 Year)
Sponsor
Dana-Farber Cancer Institute · other
Contacts & investigators
ContactJonathan Leeman, MD · contact · JONATHANE_LEEMAN@DFCI.HARVARD.EDU · 617-732-6452
InvestigatorJonathan Leeman, MD · principal_investigator, Brigham and Women's Hospital
All locations (2)
Brigham & Women's HospitalRecruiting
Boston, Massachusetts, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Stereotactic Magnetic Resonance Guided Radiation Therapy · TrialPath