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