RecruitingInterventional

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

NCT ID: NCT04115254Sponsor: Dana-Farber Cancer InstituteLast updated: 2025-11-13

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.

Arms & interventions

RadiationMR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator

Outcome measures

Primary

Delivery Success Rate for SMART across multiple tumors-Phase I
Enrolling patients and delivering SMART on the MR Linac
Time frame: 1 year
Tumor visualization-Phase I
Assessing tumor using MR guidance before, during and after MR-guided treatment patient
Time frame: 1 Year
Plan creation-Phase I
Generating adaptive plans
Time frame: 1 Year
Rate of Improvement in Tumor Control-Phase II
Statistical power will be defined in each cohort individually and will be specific to each disease site tested.
Time frame: 1 Year

Secondary

Number of Patients with Acute Toxicity-Phase I
Time frame: 90 Days
Duration of treatment-Phase 1
Time frame: 90 Days
Number of treatment fractions-Phase1
Time frame: 90 Days
Number of Participants with long term toxicity-Phase II
Time frame: 365 Days
Disease Specific Survival Rate-Phase II
Time frame: 365 Days
Overall Survival Rate-Phase II
Time frame: 365

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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 locations (2)

Brigham & Women's Hospital

Boston, Massachusetts, 02115

Recruiting

Jonathan Leeman, MD · Contact

Jonathan Leeman, MD · Principal Investigator

Dana Farber Cancer Institute

Boston, Massachusetts, 02115

Recruiting

Jonathan Leeman, MD · Contact

Jonathan Leeman, MD · Principal Investigator

References

Leeman JE, Shin KY, Droznin A, Catalano P, Cagney DN, Singer L, Oniyangi RD, Zhai K, Benham G, Chirmade S, Campbell J, Boyle S, Saranteas A, Williams CL, Huynh E, Han Z, Sudhyadhom A, Hu YH, Ferguson D, Singhrao K, Hsu SH, Bredfeldt J, Martin NE, Mancias JD, Mamon HJ, Van Dams R, Venkatachalam V, Tanguturi SK, Huynh MA, Fitzgerald KJ, Elhalawani H, Bitterman DS, Schoenfeld JD, Nguyen P, Haas-Kogan DA, Mak R. Stereotactic magnetic resonance imaging-guided adaptive radiotherapy: a pooled analysis of a master prospective trial. J Natl Cancer Inst. 2025 Nov 1;117(11):2289-2297. doi: 10.1093/jnci/djaf208.(PubMed)