Stereotactic Magnetic Resonance Guided Radiation Therapy
A Master Protocol of Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy (SMART)
1 other identifier
interventional
397
1 country
2
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 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2019
CompletedFirst Posted
Study publicly available on registry
October 3, 2019
CompletedStudy Start
First participant enrolled
October 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
November 13, 2025
November 1, 2025
8.6 years
September 26, 2019
November 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Delivery Success Rate for SMART across multiple tumors-Phase I
Enrolling patients and delivering SMART on the MR Linac
1 year
Tumor visualization-Phase I
Assessing tumor using MR guidance before, during and after MR-guided treatment patient
1 Year
Plan creation-Phase I
Generating adaptive plans
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.
1 Year
Secondary Outcomes (6)
Number of Patients with Acute Toxicity-Phase I
90 Days
Duration of treatment-Phase 1
90 Days
Number of treatment fractions-Phase1
90 Days
Number of Participants with long term toxicity-Phase II
365 Days
Disease Specific Survival Rate-Phase II
365 Days
- +1 more secondary outcomes
Study Arms (19)
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pancreatic
EXPERIMENTALSMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Renal
EXPERIMENTALSMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Central Lung
EXPERIMENTALSMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Adrenal Metastases
EXPERIMENTALSMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Liver Metastases
EXPERIMENTALSMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Metachronous Oligometastatic Nodes
EXPERIMENTALSMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Oligoprogressive Oligometastatic Nodes/Soft Tissue
EXPERIMENTALSMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Synchronous Oligometastatic Nodes/Soft Tissue
EXPERIMENTALSMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate
EXPERIMENTALSMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Borderline Resectable Pancreas
EXPERIMENTALSMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Brain Metastases
EXPERIMENTALSMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mesothelioma
EXPERIMENTALSMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate Boost
EXPERIMENTALSMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pelvic Re-Irradiation
EXPERIMENTALSMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Spine
EXPERIMENTALSMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Single-Fraction Kidney Tumors
EXPERIMENTALSMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--1/3 Fraction for Oligometastatases in the Abdomen/Pelvis
EXPERIMENTALSMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Post-Operative Radiation Therapy in Lung Cancer
EXPERIMENTALSMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mediastinal and Hilar Lymph Nodes
EXPERIMENTALSMART will be administered per each individual disease site standards
Interventions
Radiation will be delivered on an MR-guided Linear Accelerator
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Related Publications (1)
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.
PMID: 40794880DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Leeman, MD
Brigham and Women's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 26, 2019
First Posted
October 3, 2019
Study Start
October 22, 2019
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
November 13, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- BWH - Contact the Partners Innovations team at http://www.partners.org/innovation
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Dr. Jonathan Leeman (jonathane\_leeman@dfci.harvard.edu). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.