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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT03495115
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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)

Key Dates

Start date
Apr 18, 2018
Status verified
Mar 2026
Primary completion
Dec 30, 2023
Completion
Dec 30, 2023

Study Design

Enrollment
460 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Active Comparator: Conventional Breast MRI
    Standard MRI procedure will be used.
  • Experimental: Restriction Spectrum Imaging
    * RSI is a DWI sequence with a built in distortion-correction technique that can be applied to any diffusion technique using echo planar imaging acquisition. * RSI will be performed using pulsed-field gradient, spin-echo, echo planar imaging with "multi-shell" diffusion data . * The b0 images will be collected in both the forward and reverse phase encoding directions to allow for post-processing correction of spatial distortion from magnetic field.

Primary Outcome Measure

Diagnostic Accuracy of Restriction Spectrum Imaging (RSI) in Comparison to Conventional Breast MRI for Detection of Breast Cancer in the Screening Population. [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Beth Israel Deaconess Medical Center· Boston, MA

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