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A Master Protocol of Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy (SMART)


Trial ID:NCT04115254

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Protocol #:19-353

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

Condition(s):Adrenal Metastases, Borderline Resectable Pancreatic Carcinoma, Brain Metastases, Liver Metastases, Lung Cancer, Mesothelioma, Metachronous Nodal Metastases, Oligoprogressive Nodal Metastases, Pancreas Cancer, Prostate Cancer, Renal Cancer, Spine Metastases, Synchronous Nodal Metastases


Principal Investigator:Leeman, Jonathan

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

Trial Description:
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

Eligibility Requirements:
- 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

Protocol #: 19-353

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