N/A
N=460
Comparing Restriction Spectrum Imaging (RSI) to Conventional and Abbreviated Breast MRI for Breast Cancer Screening
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03495115 ↗Enrolled (actual)
460
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Diagnostic Accuracy of Restriction Spectrum Imaging (RSI) in Comparison to Conventional Breast MRI for Detection of Breast Cancer in the Screening Population. — 34; 0 participants with identified cancer — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MRI (Device); RSI (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Accuracy of Restriction Spectrum Imaging (RSI) in Comparison to Conventional Breast MRI for Detection of Breast Cancer in the Screening Population. |
34; 0 | <0.05 sig |
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)
Eligibility Criteria
Inclusion Criteria
- 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
Inclusion Criteria
- Must have clinical experience in interpreting breast MRI.
- Must have interpreted at least 10 breast MRI exams with RSI interpretation.
Exclusion Criteria
-Known or suspected renal insufficiency, rendering the participant unable to safely receive intravenous contrast based on institutional clinical protocol.
Renal insufficiency for the purposes of exclusion includes any of the following:
- Failed Chokye questionnaire
- Known history of end stage renal disease with EGFR 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.
- Presence of MRI unsafe devices or objects which would make having an MRI unsafe, as per institutional clinical protocol. MRI unsafe devices or objects for the purposes of exclusion include but are not limited to certain intracranial aneurysm clips, cardiac pacemaker, and implantable defibrillator devices, metallic heart valve, or coronary artery stents, breast tissue expanders, bio or neurostimulators, pellets and bullets, ocular implants and devices, otologic and cochlear implants. Other devices or metallic objects may be deemed unsafe for MRI at the radiologist's discretion.
- 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.
Data sourced from ClinicalTrials.gov (NCT03495115). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.