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NCT Number: NCT04115254

Stereotactic Magnetic Resonance Guided Radiation Therapy

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

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Key information

Conditions

Pancreas Cancer Adenoma Adrenal Metastases Borderline Resectable Pancreatic Carcinoma Brain Diseases Brain Metastases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Kidney Diseases Kidney Neoplasms Liver Metastases Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Mesothelioma Metachronous Nodal Metastases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Nervous System Diseases Nervous System Neoplasms Oligoprogressive Nodal Metastases Pancreatic Diseases Pancreatic Neoplasms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Renal Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Spine Metastases Synchronous Nodal Metastases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham & Women's Hospital, Boston, Massachusetts, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MR-guided Linac

Radiation

Radiation will be delivered on an MR-guided Linear Accelerator

Primary outcomes

  1. Delivery Success Rate for SMART across multiple tumors-Phase I

    Time frame: 1 year

    Enrolling patients and delivering SMART on the MR Linac

  2. Tumor visualization-Phase I

    Time frame: 1 Year

    Assessing tumor using MR guidance before, during and after MR-guided treatment patient

  3. Plan creation-Phase I

    Time frame: 1 Year

    Generating adaptive plans

  4. Rate of Improvement in Tumor Control-Phase II

    Time frame: 1 Year

    Statistical power will be defined in each cohort individually and will be specific to each disease site tested.

Secondary outcomes

  1. Number of Patients with Acute Toxicity-Phase I

    Time frame: 90 Days

    Any related ≥ Grade 3 AE which is possibly, probably or definitely related to SMART

  2. Duration of treatment-Phase 1

    Time frame: 90 Days

    Duration of treatment with goal of >80% of cases treated within 90 minutes

  3. Number of treatment fractions-Phase1

    Time frame: 90 Days

    Number of treatment fractions that would have resulted in unacceptably high dose (exceeding constraint) to an OAR without SMART

  4. Number of Participants with long term toxicity-Phase II

    Time frame: 365 Days

    assessing long-term (12 month) toxicity in patients receiving SMART

  5. Disease Specific Survival Rate-Phase II

    Time frame: 365 Days

    Kaplan-Meier curve estimates

  6. Overall Survival Rate-Phase II

    Time frame: 365

    Kaplan-Meier curve estimates

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan Leeman, MD

CONTACT

[email protected]

617-732-6452

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

A Master Protocol of Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy (SMART)

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Oct 3, 2019
Registry last updated
Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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