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Completed INTERVENTIONAL NCT03495115

Comparing Restriction Spectrum Imaging (RSI) to Conventional and Abbreviated Breast MRI for Breast Cancer Screening

Sponsor: Beth Israel Deaconess Medical Center

Conditions Breast Cancer
Interventions MRI RSI
Updated 12 times since 2018 Last updated: Mar 30, 2026 Started: Apr 18, 2018 Primary completion: Dec 30, 2023 Completion: Dec 30, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Breast Cancer, this trial is completed. The trial is conducted by Beth Israel Deaconess Medical Center and has accumulated 12 data snapshots since 2018. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Study Description(click to expand)

The primary purpose of this research study is to measure RSI's ability to diagnose breast cancer in comparison to standard breast MRIs. RSI is a technique that has been shown to address the limitations of certain types of MRI exams used to make images of the prostate and brain. RSI is not a FDA-approved technique for screening, but is a type of advanced diffusion technique and diffusion weighted imaging is used as a part of the standard breast MRI. RSI has been shown to improve tumor detection in prostate and brain. For example, a recent pilot study in prostate showed that adding RSI improved the ability to find a certain stage of prostate cancer in comparison to an MRI without the use of the RSI technique. By comparing RSI's ability to diagnose breast cancer, future clinical testing can determine whether RSI is a more efficient way to screen for breast cancer.

The primary purpose of this research study is to measure RSI's ability to diagnose breast cancer in comparison to standard breast MRIs.

RSI is a technique that has been shown to address the limitations of certain types of MRI exams used to make images of the prostate and brain. RSI is not a FDA-approved technique for screening, but is a type of advanced diffusion technique and diffusion weighted imaging is used as a part of the standard breast MRI. RSI has been shown to improve tumor detection in prostate and brain. For example, a recent pilot study in prostate showed that adding RSI improved the ability to find a certain stage of prostate cancer in comparison to an MRI without the use of the RSI technique. By comparing RSI's ability to diagnose breast cancer, future clinical testing can determine whether RSI is a more efficient way to screen for breast cancer.

Status Flow

~May 2018 – ~Aug 2018 · 3 months · monthly snapshotNot Yet Recruiting~Aug 2018 – ~Feb 2020 · 18 months · monthly snapshotRecruiting~Feb 2020 – ~Jan 2021 · 11 months · monthly snapshotActive Not Recruiting~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshotActive Not Recruiting~Mar 2021 – ~Sep 2021 · 6 months · monthly snapshotActive Not Recruiting~Sep 2021 – ~Mar 2023 · 18 months · monthly snapshotActive Not Recruiting~Mar 2023 – ~Jul 2023 · 4 months · monthly snapshotActive Not Recruiting~Jul 2023 – ~Jul 2024 · 12 months · monthly snapshotActive Not Recruiting~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshotActive Not Recruiting~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshotCompleted~Sep 2024 – ~Apr 2026 · 20 months · monthly snapshotCompletedApr 18, 2026 – present · 3 months · daily APICompleted

Change History

12 versions recorded
  1. Apr 18, 2026 — Present [daily]

    Completed

    Phase: NANone

  2. Sep 2024 — Apr 2026 [monthly]

    Completed NA

  3. Aug 2024 — Sep 2024 [monthly]

    Completed NA

    Status: Active Not RecruitingCompleted

  4. Jul 2024 — Aug 2024 [monthly]

    Active Not Recruiting NA

  5. Jul 2023 — Jul 2024 [monthly]

    Active Not Recruiting NA

Show 7 earlier versions
  1. Mar 2023 — Jul 2023 [monthly]

    Active Not Recruiting NA

  2. Sep 2021 — Mar 2023 [monthly]

    Active Not Recruiting NA

  3. Mar 2021 — Sep 2021 [monthly]

    Active Not Recruiting NA

  4. Jan 2021 — Mar 2021 [monthly]

    Active Not Recruiting NA

  5. Feb 2020 — Jan 2021 [monthly]

    Active Not Recruiting NA

    Status: RecruitingActive Not Recruiting

  6. Aug 2018 — Feb 2020 [monthly]

    Recruiting NA

    Status: Not Yet RecruitingRecruiting

  7. May 2018 — Aug 2018 [monthly]

    Not Yet Recruiting NA

    First recorded

Apr 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

This study is looking at a breast cancer screening technique, restriction spectrum imaging (RSI), as a possible alternative to the breast Magnetic Resonance Imaging (MRI) used by most healthcare professionals. The technique involved in this study is: -Restriction Spectrum Imaging (RSI)

Contact Information

Sponsor contact:
  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute
  • Radiological Society of North America
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations