NCT03495115

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 460 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	MRI	A MRI uses a strong magnet to produce detailed pictures of the inside of your body.
DEVICE	RSI	RSI is a technique that aims to improve the pictures produced during a MRI exam.

Timeline

• Start date: 2018-04-18
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2018-04-11
• Last updated: 2026-04-17
• Results posted: 2026-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study