Stereotactic Magnetic Resonance Guided Radiation Therapy

NCT ID: NCT04115254

Last Updated: 2025-11-13

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

397 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-22

Study Completion Date

2028-06-30

Brief Summary

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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.

* 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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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.

Conditions

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Pancreas Cancer Lung Cancer Renal Cancer Adrenal Metastases Prostate Cancer Liver Metastases Oligoprogressive Nodal Metastases Metachronous Nodal Metastases Synchronous Nodal Metastases Mesothelioma Spine Metastases Brain Metastases Borderline Resectable Pancreatic Carcinoma

Keywords

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Magnetic Resonance Imaging (MRI) MRIdian Linear Accelerator Pancreas Cancer Lung Cancer Renal Cancer Adrenal Metastases Prostate Cancer Liver Metastases Oligoprogressive Metachronous Synchronous Spine Prostate Boost Pelvic Re Irradiation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

MR-guided Linac

Intervention Type RADIATION

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

Group Type EXPERIMENTAL

MR-guided Linac

Intervention Type RADIATION

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

Group Type EXPERIMENTAL

MR-guided Linac

Intervention Type RADIATION

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

Group Type EXPERIMENTAL

MR-guided Linac

Intervention Type RADIATION

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

Group Type EXPERIMENTAL

MR-guided Linac

Intervention Type RADIATION

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

Group Type EXPERIMENTAL

MR-guided Linac

Intervention Type RADIATION

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

Group Type EXPERIMENTAL

MR-guided Linac

Intervention Type RADIATION

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

Group Type EXPERIMENTAL

MR-guided Linac

Intervention Type RADIATION

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

Group Type EXPERIMENTAL

MR-guided Linac

Intervention Type RADIATION

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

Group Type EXPERIMENTAL

MR-guided Linac

Intervention Type RADIATION

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

Group Type EXPERIMENTAL

MR-guided Linac

Intervention Type RADIATION

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

Group Type EXPERIMENTAL

MR-guided Linac

Intervention Type RADIATION

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

Group Type EXPERIMENTAL

MR-guided Linac

Intervention Type RADIATION

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

Group Type EXPERIMENTAL

MR-guided Linac

Intervention Type RADIATION

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

Group Type EXPERIMENTAL

MR-guided Linac

Intervention Type RADIATION

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

Group Type EXPERIMENTAL

MR-guided Linac

Intervention Type RADIATION

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

Group Type EXPERIMENTAL

MR-guided Linac

Intervention Type RADIATION

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

Group Type EXPERIMENTAL

MR-guided Linac

Intervention Type RADIATION

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

Group Type EXPERIMENTAL

MR-guided Linac

Intervention Type RADIATION

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Leeman, MD

Principal Investigator

Responsibility Role 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

Site Status RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jonathan Leeman, MD

Role: CONTACT

Phone: 617-732-6452

Email: [email protected]

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.

Reference Type DERIVED
PMID: 40794880 (View on PubMed)

Other Identifiers

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19-353

Identifier Type: -

Identifier Source: org_study_id