Status:
RECRUITING
Stereotactic Magnetic Resonance Guided Radiation Therapy
Lead Sponsor:
Dana-Farber Cancer Institute
Conditions:
Pancreas Cancer
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 phas...
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 A...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
397 Patients enrolled
Trial Details
Trial ID
NCT04115254
Start Date
October 22 2019
End Date
June 1 2028
Last Update
November 13 2025
Active Locations (2)
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1
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115