Stereotactic Magnetic Resonance Guided Radiation Therapy
NCT ID: NCT04115254
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
397 participants
INTERVENTIONAL
2019-10-22
2028-06-30
Brief Summary
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* 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
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pancreatic
SMART will be administered per each individual disease site standards
MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Renal
SMART will be administered per each individual disease site standards
MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Central Lung
SMART will be administered per each individual disease site standards
MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Adrenal Metastases
SMART will be administered per each individual disease site standards
MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Liver Metastases
SMART will be administered per each individual disease site standards
MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Metachronous Oligometastatic Nodes
SMART will be administered per each individual disease site standards
MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Oligoprogressive Oligometastatic Nodes/Soft Tissue
SMART will be administered per each individual disease site standards
MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Synchronous Oligometastatic Nodes/Soft Tissue
SMART will be administered per each individual disease site standards
MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate
SMART will be administered per each individual disease site standards
MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Borderline Resectable Pancreas
SMART will be administered per each individual disease site standards
MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Brain Metastases
SMART will be administered per each individual disease site standards
MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mesothelioma
SMART will be administered per each individual disease site standards
MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate Boost
SMART will be administered per each individual disease site standards
MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pelvic Re-Irradiation
SMART will be administered per each individual disease site standards
MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Spine
SMART will be administered per each individual disease site standards
MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Single-Fraction Kidney Tumors
SMART will be administered per each individual disease site standards
MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--1/3 Fraction for Oligometastatases in the Abdomen/Pelvis
SMART will be administered per each individual disease site standards
MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Post-Operative Radiation Therapy in Lung Cancer
SMART will be administered per each individual disease site standards
MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mediastinal and Hilar Lymph Nodes
SMART will be administered per each individual disease site standards
MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Interventions
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MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Dana-Farber Cancer Institute
OTHER
Responsible Party
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Jonathan Leeman, MD
Principal Investigator
Principal Investigators
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Jonathan Leeman, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Brigham & Women's Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Jonathan Leeman, MD
Role: primary
Jonathan Leeman, MD
Role: primary
References
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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 MRI Guided Adaptive Radiotherapy: a pooled analysis of a master prospective trial. J Natl Cancer Inst. 2025 Aug 6:djaf208. doi: 10.1093/jnci/djaf208. Online ahead of print.
Other Identifiers
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19-353
Identifier Type: -
Identifier Source: org_study_id