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

NCT03495115 | Completed Results FDA Device

• 1 other identifier: 17-552
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of Restriction Spectrum Imaging (RSI) in Comparison to Conventional Breast MRI for Detection of Breast Cancer in the Screening Population.

  Comparison of participants with cancer in the DCE- MRI group compared to RSI group. Review of the examinations was performed by 3 expert breast imagers and number of cancers detected in each group were compared.

  2 years

Study Arms (2)

Conventional Breast MRI

ACTIVE COMPARATOR

Standard MRI procedure will be used.

Device: MRI

Restriction Spectrum Imaging

EXPERIMENTAL

* 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.

Device: RSI

Interventions

MRI DEVICE

A MRI uses a strong magnet to produce detailed pictures of the inside of your body.

Conventional Breast MRI

RSI DEVICE

RSI is a technique that aims to improve the pictures produced during a MRI exam.

Restriction Spectrum Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Group 1 will consist of women who present for screening breast MRI:
• Age \>= 18
• Female
• Asymptomatic for breast disease
• Presenting for routine breast cancer screening with MRI
• Group 2 will consist of women who presented for a screening mammogram (2D or 3D tomosynthesis) AND who have had a biopsy recommended after diagnostic workup:
• Age \>= 18
• Female
• Asymptomatic for breast disease
• Presenting for routine breast cancer screening with mammogram (2D or 3D tomosynthesis) and/or ultrasound
• Biopsy recommended after subsequent diagnostic workup (BI-RADS 4 or 5)
• Radiologist Reader Participant
• Must have clinical experience in interpreting breast MRI.
• Must have interpreted at least 10 breast MRI exams with RSI interpretation.

You may not qualify if:

• Known or suspected renal insufficiency, rendering the participant unable to safely receive intravenous contrast based on institutional clinical protocol.
• Failed Chokye questionnaire
• Known history of end stage renal disease with EGFR\<30 mL/min/1.73m2
• Point of care (POC) measure of creatinine clearance (eGFR) prior to obtaining the MRI \<35. We will perform this POC test as needed per institutional policy for routine MRI if: (a) no creatinine result is available in the OMR within 30 days of the MRI exam, (b) the patient is \> 60 years old, or (c) the patient is on hydroxyurea.
• History of adverse or allergic-like reaction to gadolinium MRI intravenous contrast, rendering the participant unable to safely receive intravenous contrast based on institutional clinical protocol.
• Unable to tolerate exam (i.e., secondary to untreatable claustrophobia, positioning constraints/unable to lie prone).
• Body weight exceeds that allowable by the MRI table.
• Breast biopsy or surgical intervention planned before the test RSI-MRI in this study.
• Breast implants (silicone or saline).
• \. Nursing or thinks she may be or is pregnant, as gadolinium contrast-enhanced MRI is unsafe. We will perform a pregnancy test as needed per institutional policy for routine breast MRI. Per institutional clinical protocol, all females of childbearing potential who are uncertain if they are pregnant or think they are pregnant must have a blood test or urine study within 2 weeks prior to the MRI exam to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or prior tubal ligation, who:
• Has not had a hysterectomy or bilateral oophorectomy OR
• Has not been naturally post-menopausal for at least 2 years (i.e., has had menses at any time in the preceding 2 years
• Radiologist Reader Participant
• None.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Radiological Society of North America: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Vandana Dialani, MD
• Organization: BIDMC

vdialani@bidmc.harvard.edu

617-667-5698

Study Officials

• Vandana Dialani, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 11, 2018
• Study Start: April 18, 2018
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: April 17, 2026
• Results First Posted: April 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)