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New breast scan could rival MRI for cancer detection

NCT ID NCT03495115

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new imaging technique called restriction spectrum imaging (RSI) to see if it can find breast cancer as well as standard breast MRI. About 460 women who were getting routine breast cancer screening took part. The goal was to compare how accurate RSI is versus conventional MRI for detecting cancer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

460 people

The number who actually took part.

Started

Apr 2018

Finished

Dec 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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\<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. * 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). 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: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.