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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pancreatic | Experimental | SMART will be administered per each individual disease site standards |
|
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Renal | Experimental | SMART will be administered per each individual disease site standards |
|
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Central Lung | Experimental | SMART will be administered per each individual disease site standards |
|
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Adrenal Metastases | Experimental | SMART will be administered per each individual disease site standards |
|
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Liver Metastases | Experimental | SMART will be administered per each individual disease site standards |
|
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Metachronous Oligometastatic Nodes |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR-guided Linac | Radiation | Radiation will be delivered on an MR-guided Linear Accelerator |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients with Acute Toxicity-Phase I | Any related ≥ Grade 3 AE which is possibly, probably or definitely related to SMART | 90 Days |
| Duration of treatment-Phase 1 | Duration of treatment with goal of >80% of cases treated within 90 minutes |
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Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Leeman, MD | Contact | 617-732-6452 | JONATHANE_LEEMAN@DFCI.HARVARD.EDU |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Leeman, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham & Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40794880 | Derived | 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. |
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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.
Data can be shared no earlier than 1 year following the date of publication
BWH - Contact the Partners Innovations team at http://www.partners.org/innovation
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All participants will be assigned to one treatment arm only depending on their cancer type, and will be taken off study once treatment and follow up are complete.
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| Experimental |
SMART will be administered per each individual disease site standards |
|
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Oligoprogressive Oligometastatic Nodes/Soft Tissue | Experimental | SMART will be administered per each individual disease site standards |
|
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Synchronous Oligometastatic Nodes/Soft Tissue | Experimental | SMART will be administered per each individual disease site standards |
|
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate | Experimental | SMART will be administered per each individual disease site standards |
|
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Borderline Resectable Pancreas | Experimental | SMART will be administered per each individual disease site standards |
|
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Brain Metastases | Experimental | SMART will be administered per each individual disease site standards |
|
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mesothelioma | Experimental | SMART will be administered per each individual disease site standards |
|
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate Boost | Experimental | SMART will be administered per each individual disease site standards |
|
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pelvic Re-Irradiation | Experimental | SMART will be administered per each individual disease site standards |
|
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Spine | Experimental | SMART will be administered per each individual disease site standards |
|
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Single-Fraction Kidney Tumors | Experimental | SMART 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 | Experimental | SMART will be administered per each individual disease site standards |
|
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Post-Operative Radiation Therapy in Lung Cancer | Experimental | SMART will be administered per each individual disease site standards |
|
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mediastinal and Hilar Lymph Nodes | Experimental | SMART will be administered per each individual disease site standards |
|
| 90 Days |
| Number of treatment fractions-Phase1 | Number of treatment fractions that would have resulted in unacceptably high dose (exceeding constraint) to an OAR without SMART | 90 Days |
| Number of Participants with long term toxicity-Phase II | assessing long-term (12 month) toxicity in patients receiving SMART | 365 Days |
| Disease Specific Survival Rate-Phase II | Kaplan-Meier curve estimates | 365 Days |
| Overall Survival Rate-Phase II | Kaplan-Meier curve estimates | 365 |
| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D008175 | Lung Neoplasms |
| D007680 | Kidney Neoplasms |
| D011471 | Prostatic Neoplasms |
| D008654 | Mesothelioma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D011469 | Prostatic Diseases |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018301 | Neoplasms, Mesothelial |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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