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New MRI method could spot breast cancer better in dense breasts

NCT ID NCT02933489

Diagnosis Sponsor: ECOG-ACRIN Cancer Research Group Source: ClinicalTrials.gov ↗

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a quick, low-cost breast MRI (about 10 minutes) finds cancer better than standard 3D mammography in women with dense breast tissue. Over 1,500 women without symptoms took part. The goal is to see which method catches more invasive cancers early, potentially improving screening for those at higher risk due to dense breasts.

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

1,516 people

The number who actually took part.

Started

Dec 2016

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Ages

40 to 75 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Patents must be scheduled for routine screening DBT * Women must not be pregnant or breast-feeding; all females of childbearing potential who are uncertain if they could be pregnant or may be pregnant or as per local site standard of practice in women undergoing DBT and MRI must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Women of childbearing potential must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the following year until the year 1 AB-MR and DBT studies are performed * Patient?s breast density must be known; patients must have mammographically dense breasts, American College of Radiology \[ACR\] Breast Imaging \[BI\]- Reporting and Data System Atlas (RADS) lexicon categories c or d (heterogeneous or extreme fibroglandular tissue) on their most-recent prior screening * Patient must be asymptomatic for breast disease and undergoing routine screening * Patient must have no known breast cancer (DCIS or invasive cancer), not currently undergoing treatment for breast cancer, or planning surgery for a high risk lesion (atypical ductal breast hyperplasia \[ADH\], atypical lobular breast hyperplasia \[ALH\], lobular breast carcinoma in situ \[LCIS\], papilloma, radial scar) * Patient must not be taking chemoprevention for breast cancer * Patient must not have undergone breast ultrasound within 12 months prior to randomization * Patient must not have previously had a breast MRI * Patient must not have previously had molecular breast imaging (MBI, multiplexed ion beam imaging \[MIBI\]) * Patient must agree to not undergo screening ultrasound (of breast) for the duration of the 1 year study period * Patient must not be suspected of being at high-risk for breast cancer, as defined by the American Cancer Society (ACS) breast MR screening recommendations (lifetime risk of \>= 20-25%) * Patient must be able to undergo breast MRI with contrast enhancement; patients unable to undergo breast MRI with contrast enhancement for any reason are ineligible * No history of untreatable claustrophobia * No presence of non MR compatible metallic objects or metallic objects that, in the opinion of the radiologist, would make MRI a contraindication * No history of sickle cell disease * No contraindication to intravenous contrast administration * No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance * No known or suspected renal impairment; requirements for glomerular filtration rate (GFR) prior to MRI as determined by local site standard practice * Weight less than or equal to the MRI table limit * No women who have had prior contrast enhanced mammography (contrast enhanced spectral mammography \[CESM\] or contrast enhanced digital mammography \[CEDM\]) * No women who have breast prosthetic implants (silicone or saline) Exclusion Criteria

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Conditions

The condition(s) this trial relates to.

breast cancer

As listed by the trial registrant

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

Asymptomatic

Contacts and locations

Locations

  • Aultman Health Foundation

    Canton, Ohio, 44710, United States

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Baylor University Medical Center

    Dallas, Texas, 75246, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486, United States

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203, United States

  • Case Western Reserve University

    Cleveland, Ohio, 44106, United States

  • Clinical Radiologists SC

    Springfield, Illinois, 62781, United States

  • Diagnostic Center for Women LLC

    Miami, Florida, 33173, United States

  • ECOG-ACRIN Cancer Research Group

    Philadelphia, Pennsylvania, 19103, United States

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805, United States

  • Farmington Health Center

    Farmington, Utah, 84025, United States

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109, United States

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822, United States

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601, United States

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713, United States

  • Huntington Memorial Hospital

    Pasadena, California, 91105, United States

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112, United States

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202, United States

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287, United States

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805, United States

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980, United States

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065, United States

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503, United States

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467-2490, United States

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461, United States

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Norwalk Hospital

    Norwalk, Connecticut, 06856, United States

  • Novant Health Forsyth Medical Center

    Winston-Salem, North Carolina, 27103, United States

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121, United States

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403, United States

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850, United States

  • ProHealth D N Greenwald Center

    Mukwonago, Wisconsin, 53149, United States

  • ProHealth Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066, United States

  • ProHealth Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188, United States

  • Queen's Medical Center

    Honolulu, Hawaii, 96813, United States

  • Radiology Imaging Associates

    Englewood, Colorado, 80112, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Riverview Medical Center/Booker Cancer Center

    Red Bank, New Jersey, 07701, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • Rwth Klinikum Aachen

    Aachen, 52074, Germany

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109, United States

  • Sentara Leigh Hospital

    Norfolk, Virginia, 23502, United States

  • Sentara Martha Jefferson Hospital

    Charlottesville, Virginia, 22901, United States

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507, United States

  • South Jordan Health Center

    South Jordan, Utah, 84009, United States

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303, United States

  • The Community Hospital

    Munster, Indiana, 46321, United States

  • The Women's Imaging Center

    Denver, Colorado, 80209, United States

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911, United States

  • UHHS-Westlake Medical Center

    Westlake, Ohio, 44145, United States

  • UW Cancer Center at ProHealth Care

    Waukesha, Wisconsin, 53188, United States

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637, United States

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160, United States

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104, United States

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792, United States

  • Vanderbilt Breast Center at One Hundred Oaks

    Nashville, Tennessee, 37204, United States

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007, United States

More trials for these conditions

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