Recruiting

Stereotactic MR Guided Radiation Therapy

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT04115254

Conditions

Pancreas Cancer

Lung Cancer

Renal Cancer

Adrenal Metastases

Prostate Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MR-guided Linac

Study Details

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

Conditions

Pancreas Cancer

Lung Cancer

Renal Cancer

Adrenal Metastases

Prostate Cancer

Study ID

NCT04115254

Start date

Oct 22, 2019

Status verified date

Nov, 2025

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

397 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pancreatic

SMART will be administered per each individual disease site standards

experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Renal

SMART will be administered per each individual disease site standards

experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Central Lung

SMART will be administered per each individual disease site standards

experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Adrenal Metastases

SMART will be administered per each individual disease site standards

experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Liver Metastases

SMART will be administered per each individual disease site standards

experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Metachronous Oligometastatic Nodes

SMART will be administered per each individual disease site standards

experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Oligoprogressive Oligometastatic Nodes/Soft Tissue

SMART will be administered per each individual disease site standards

experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Synchronous Oligometastatic Nodes/Soft Tissue

SMART will be administered per each individual disease site standards

experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate

SMART will be administered per each individual disease site standards

experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Borderline Resectable Pancreas

SMART will be administered per each individual disease site standards

experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Brain Metastases

SMART will be administered per each individual disease site standards

experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mesothelioma

SMART will be administered per each individual disease site standards

experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate Boost

SMART will be administered per each individual disease site standards

experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pelvic Re-Irradiation

SMART will be administered per each individual disease site standards

experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Spine

SMART will be administered per each individual disease site standards

experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Single-Fraction Kidney Tumors

SMART will be administered per each individual disease site standards

experimental: 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

experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Post-Operative Radiation Therapy in Lung Cancer

SMART will be administered per each individual disease site standards

experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mediastinal and Hilar Lymph Nodes

SMART will be administered per each individual disease site standards

Interventions

MR-guided Linac

Radiation will be delivered on an MR-guided Linear Accelerator

Primary outcome measure

  • Delivery Success Rate for SMART across multiple tumors-Phase I [ Time Frame: 1 year ]
  • Tumor visualization-Phase I [ Time Frame: 1 Year ]
  • Plan creation-Phase I [ Time Frame: 1 Year ]
  • Rate of Improvement in Tumor Control-Phase II [ Time Frame: 1 Year ]

Central Contacts and Locations

Central contacts

Jonathan Leeman, MD

617-732-6452JONATHANE_LEEMAN@DFCI.HARVARD.EDU

Locations

Brigham & Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator:

Jonathan Leeman, MD

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator:

Jonathan Leeman, MD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Nov 13, 2025

Last verified

Nov, 2025

Keywords

  • 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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2025-11-13.