An interventional study of MRI and RSI in Breast Cancer, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Screening
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)
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.
Inclusion Criteria:
Group 1 will consist of women who present for screening breast 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:
Radiologist Reader Participant
Inclusion Criteria
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:
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.
Breast implants (silicone or saline).
8. 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:
Radiologist Reader Participant
-None.
Standard MRI procedure will be used.
Device: MRI
* 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
A MRI uses a strong magnet to produce detailed pictures of the inside of your body.
RSI is a technique that aims to improve the pictures produced during a MRI exam.
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.
Time frame: 2 years
Group1- Conventional Breast MRI Group 2 - Restriction spectrum imaging
| Milestone | Screening Breast MRI Versus Restriction Spectrum Imaging |
|---|---|
| Started | 460 |
| Completed | 460 |
| Not completed | 0 |
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.
| participants with identified cancer | DCE MRI | Restriction Spectrum Imaging (RSI) |
|---|---|---|
| Diagnostic Accuracy of Restriction Spectrum Imaging (RSI) in Comparison to Conventional Breast MRI for Detection of Breast Cancer in the Screening Population. | 34 | 0 |
Collected over This was an imaging study and there is no treatment arm. The adverse effects were related to IV contrast administration and thus collected at the time of contrast administration. The patient was monitored when the imaging study was performed for adverse contrast reaction for that day of the study performed. There was no follow-up for adverse events as there was no intervention done.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Conventional Breast MRI | 0/460 (0%) | 0/460 (0%) | 0/460 (0%) |
| Restriction Spectrum Imaging | 0/460 (0%) | 0/460 (0%) | 0/460 (0%) |
| Age, Categorical(Participants) | Screening Breast MRI Versus Restriction Spectrum Imaging |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 400 |
| >=65 years | 60 |
| Sex/Gender, Customized(Participants) | Screening Breast MRI Versus Restriction Spectrum Imaging |
|---|---|
| SEX — FEMALE | 460 |
| SEX — MALE | 0 |
| Race and Ethnicity Not Collected(Participants) | Screening Breast MRI Versus Restriction Spectrum Imaging |
|---|
| Region of Enrollment(Participants) | Screening Breast MRI Versus Restriction Spectrum Imaging |
|---|---|
| United States | 460 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Beth Israel Deaconess Medical Center