Stereotactic Magnetic Resonance Guided Radiation Therapy

Last updated: November 11, 2025
Sponsor: Dana-Farber Cancer Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Renal Cancer

Cancer

Urothelial Cancer

Treatment

MR-guided Linac

Clinical Study ID

NCT04115254
19-353
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must have a confirmed malignancy requiring stereotactic body radiationtherapy. 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 consentdocument.

  • Specific eligibility requirements for each disease site with be covered in eachspecific cohort.

Exclusion

Exclusion Criteria:

  • Specific exclusion requirements for each disease site with be covered in eachspecific 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

Total Participants: 397
Treatment Group(s): 1
Primary Treatment: MR-guided Linac
Phase:
Study Start date:
October 22, 2019
Estimated Completion Date:
June 30, 2028

Study Description

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.

Connect with a study center

  • Brigham & Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Brigham & Women's Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Active - Recruiting

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