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MRI before breast surgery: game changer or unnecessary extra?

NCT ID NCT01805076

Knowledge-focused Sponsor: Alliance for Clinical Trials in Oncology 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at whether women with early-stage breast cancer benefit from having a breast MRI in addition to standard mammograms before surgery. Researchers tracked 319 women to see if the MRI helped reduce the chance of cancer coming back, lowered the need for repeat surgeries, or affected costs and quality of life. The goal was to find out if the extra imaging is worth it.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could show that adding MRI before surgery helps doctors choose the best operation, potentially reducing repeat surgeries and improving long-term outcomes.
What could go wrong
This trial is completed but results may not apply to all breast cancer types. MRI can also lead to unnecessary extra procedures or anxiety without clear benefit.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

319 people

The number who actually took part.

Started

May 2014

Finished

May 2025

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.

* Female. Men are excluded from this study because the number of men with breast cancer is insufficient to provide a statistical basis for assessment of effects in this subpopulation of people with breast cancer. * Pathologically confirmed diagnosis of breast cancer, clinical stage I-II (T1-3 N0 M0, T0-2 N1 M0). Diagnosis must be by needle biopsy; patients diagnosed by surgical excision are excluded. * Patients must have either: * Estrogen receptor (ER) negative/progesterone receptor (PR) negative (\< 10% by immunohistochemistry IHC staining) and HER-2 negative breast cancer OR * ER negative/PR negative (\< 10% by IHC staining) and HER-2 positive tumors * HER-2 status will be determined as per the 2013 ASCO CAP guidelines: * HER-2 is considered positive if there is IHC 3+ staining or ISH positive using either single probe ISH or dual probe ISH * HER-2 is considered negative if there is IHC 0 or 1+ staining or ISH negative using either single probe ISH or dual probe ISH * No patients with previous ipsilateral invasive breast cancer or ductal carcinoma in situ (DCIS) * No patients with bilateral breast cancer * No patients with known deleterious mutations in breast cancer (BRCA) genes * No current history of receiving hormonal therapy, tamoxifen, and or aromatase inhibitors for therapeutic measures * No history of chemotherapy for cancer within 6 months prior to registration * No patients scheduled to receive neoadjuvant chemotherapy or partial breast irradiation following breast conserving surgery * Eligible for BCT based on clinical examination, mammography and, if standard practice at a given institution, ultrasound and/or tomogram. Women who cannot be appropriately selected for BCT based on these standard imaging studies, and for whom additional imaging is recommended to clarify local disease extent, will not be eligible for this trial. * No patients with multicentric or multifocal disease scheduled to undergo multiple lumpectomies. Multifocal disease that can be encompassed in a single operative bed can be enrolled. * Suitable to undergo MRI and receive the contrast agent gadolinium (exclusions follow): * No history of untreatable claustrophobia * No presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants) * 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 findings consistent with renal failure, as determined by glomerular filtration rate (GFR) \< 30 mL/min/1.73 m\^2 based on a creatinine level obtained within 28 days prior to registration * Weight lower than that allowable by the MRI table * No prior MRI of study breast within the 12 months prior to registration * Non-pregnant and non-lactating. Patients of child-bearing potential must have a negative pregnancy test within 7 days prior to registration. Perimenopausal patients must be amenorrheic \> 12 months to be considered not of child-bearing potential * ≥ 18 years of age * Signed study-specific informed consent prior to registration

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm estrogen-receptor negative breast cancer HER2 positive breast carcinoma progesterone-receptor negative breast cancer triple-negative breast carcinoma

As listed by the trial registrant

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

Estrogen receptor- negative breast cancer Progesterone-receptor negative breast cancer Stage IA breast cancer Stage IB breast cancer Stage II breast cancer Triple negative breast cancer

Contacts and locations

Locations

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657, United States

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068, United States

  • Ascension Providence Hospitals - Novi

    Novi, Michigan, 48374, United States

  • Ascension Saint John Hospital

    Detroit, Michigan, 48236, United States

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311, United States

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024, United States

  • Aurora Medical Center in Summit

    Summit, Wisconsin, 53066, United States

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215, United States

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233, United States

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227, United States

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Baptist Health Lexington

    Lexington, Kentucky, 40503, United States

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207, United States

  • Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

    Jonesboro, Arkansas, 72401, United States

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608, United States

  • Bay Area Tumor Institute

    Oakland, California, 94609, United States

  • Baylor University Medical Center

    Dallas, Texas, 75246, United States

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234, United States

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010, United States

  • Capital Health Medical Center-Hopewell

    Pennington, New Jersey, 08534, United States

  • Carle Cancer Center

    Urbana, Illinois, 61801, United States

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718, United States

  • Community Medical Center

    Toms River, New Jersey, 08755, United States

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156, United States

  • Cookeville Regional Medical Center

    Cookeville, Tennessee, 38501, United States

  • Dekalb Medical Center

    Decatur, Georgia, 30033, United States

  • Dickstein Cancer Treatment Center

    White Plains, New York, 10601, United States

  • Doctor's Hospital of Laredo

    Laredo, Texas, 78041, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Edward Hospital/Cancer Center

    Naperville, Illinois, 60540, United States

  • Edward Hospital/Cancer Center?Plainfield

    Plainfield, Illinois, 60585, United States

  • Elkhart Clinic

    Elkhart, Indiana, 46514-2098, United States

  • Enloe Medical Center

    Chico, California, 95926, United States

  • Epic Care Partners in Cancer Care

    Emeryville, California, 94608, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Fox Valley Surgical Associates Limited

    Appleton, Wisconsin, 54911, United States

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503, United States

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651, United States

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Holy Redeemer Hospital and Medical Center

    Meadowbrook, Pennsylvania, 19046, United States

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112, United States

  • IU Health North Hospital

    Carmel, Indiana, 46032, United States

  • IU Health West Hospital

    Avon, Indiana, 46123, United States

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202, United States

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426, United States

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287, United States

  • Kaiser Permanente - Sacramento

    Sacramento, California, 95825, United States

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051, United States

  • Kaiser Permanente Medical Center-Vacaville

    Vacaville, California, 95688, United States

  • Kaiser Permanente Northwest

    Portland, Oregon, 97227, United States

  • Kaiser Permanente San Leandro

    San Leandro, California, 94577, United States

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California, 94531, United States

  • Kaiser Permanente-Fremont

    Fremont, California, 94538, United States

  • Kaiser Permanente-Fresno

    Fresno, California, 93720, United States

  • Kaiser Permanente-Gaithersburg Medical Center

    Gaithersburg, Maryland, 20879, United States

  • Kaiser Permanente-Modesto

    Modesto, California, 95356, United States

  • Kaiser Permanente-Oakland

    Oakland, California, 94611, United States

  • Kaiser Permanente-Redwood City

    Redwood City, California, 94063, United States

  • Kaiser Permanente-Richmond

    Richmond, California, 94801, United States

  • Kaiser Permanente-Roseville

    Roseville, California, 95661, United States

  • Kaiser Permanente-San Francisco

    San Francisco, California, 94115, United States

  • Kaiser Permanente-San Rafael

    San Rafael, California, 94903, United States

  • Kaiser Permanente-Santa Rosa

    Santa Rosa, California, 95403, United States

  • Kaiser Permanente-Santa Teresa-San Jose

    San Jose, California, 95119, United States

  • Kaiser Permanente-South Sacramento

    Sacramento, California, 95823, United States

  • Kaiser Permanente-South San Francisco

    South San Francisco, California, 94080, United States

  • Kaiser Permanente-Stockton

    Stockton, California, 95210, United States

  • Kaiser Permanente-Vallejo

    Vallejo, California, 94589, United States

  • Kaiser Permanente-Walnut Creek

    Walnut Creek, California, 94596, United States

  • Kaiser San Rafael-Gallinas

    San Rafael, California, 94903, United States

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854, United States

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814, United States

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016, United States

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia, 31405, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

  • McFarland Clinic PC - Ames

    Ames, Iowa, 50010, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902, United States

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601, United States

  • Memorial Medical Center

    Springfield, Illinois, 62781, 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

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804, United States

  • Michiana Hematology Oncology PC-Elkhart

    Elkhart, Indiana, 46514, United States

  • Michiana Hematology Oncology PC-Mishawaka

    Mishawaka, Indiana, 46545, United States

  • Michiana Hematology Oncology PC-Plymouth

    Plymouth, Indiana, 46563, United States

  • Michiana Hematology Oncology PC-South Bend

    South Bend, Indiana, 46601, United States

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131, United States

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467, United States

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461, United States

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032, United States

  • New Hanover Regional Medical Center/Zimmer Cancer Center

    Wilmington, North Carolina, 28401, United States

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201, United States

  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois, 60026, United States

  • NorthShore University HealthSystem-Highland Park Hospital

    Highland Park, Illinois, 60035, United States

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005, United States

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403, United States

  • Owensboro Health Mitchell Memorial Cancer Center

    Owensboro, Kentucky, 42303, United States

  • Parkview Hospital Randallia

    Fort Wayne, Indiana, 46805, United States

  • Parkview Regional Medical Center

    Fort Wayne, Indiana, 46845, United States

  • PeaceHealth Southwest Medical Center

    Vancouver, Washington, 98664, United States

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850, United States

  • Physicians' Clinic of Iowa PC

    Cedar Rapids, Iowa, 52402, United States

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605, United States

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640, United States

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615, United States

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605, United States

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650, United States

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672, United States

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316, United States

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605, United States

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Riddle Memorial Hospital

    Media, Pennsylvania, 19063, United States

  • Robert Wood Johnson University Hospital Somerset

    Somerville, New Jersey, 08876, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229, United States

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706, United States

  • Saint Joseph Hospital - Orange

    Orange, California, 92868, United States

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106, United States

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341, United States

  • Saint Joseph's Regional Medical Center

    Paterson, New Jersey, 07503, United States

  • Saint Luke's University Hospital-Bethlehem Campus

    Bethlehem, Pennsylvania, 18015, United States

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122, United States

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104, United States

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134, United States

  • Sentara Cancer Institute at Sentara CarePlex Hospital

    Hampton, Virginia, 23666, United States

  • Sentara Leigh Hospital

    Norfolk, Virginia, 23502, United States

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507, United States

  • Sharp Memorial Hospital

    San Diego, California, 92123, United States

  • Smilow Cancer Center/Yale-New Haven Hospital

    New Haven, Connecticut, 06510, United States

  • Smilow Cancer Hospital Care Center - Guiford

    Guilford, Connecticut, 06437, United States

  • Smilow Cancer Hospital Care Center - Waterford

    Waterford, Connecticut, 06385, United States

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105, United States

  • Smilow Cancer Hospital Care Center-Fairfield

    Fairfield, Connecticut, 06824, United States

  • Smilow Cancer Hospital Care Center-Trumbull

    Trumbull, Connecticut, 06611, United States

  • Smilow Cancer Hospital-Derby Care Center

    Derby, Connecticut, 06418, United States

  • South Jordan Health Center

    South Jordan, Utah, 84009, United States

  • Southern Ohio Medical Center

    Portsmouth, Ohio, 45662, United States

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303, United States

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503, United States

  • Surgical Associates of Neenah SC

    Neenah, Wisconsin, 54956, United States

  • The Community Hospital

    Munster, Indiana, 46321, United States

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202, United States

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911, United States

  • ThedaCare Regional Medical Center - Appleton

    Appleton, Wisconsin, 54911, United States

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868, United States

  • UMass Memorial Medical Center - University Campus

    Worcester, Massachusetts, 01655, United States

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637, United States

  • University of Illinois

    Chicago, Illinois, 60612, United States

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205, United States

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, 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 Rochester

    Rochester, New York, 14642, United States

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792, United States

  • Vassar Brothers Medical Center

    Poughkeepsie, New York, 12601, United States

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904, United States

  • Vince Lombardi Cancer Clinic-Sheboygan

    Sheboygan, Wisconsin, 53081, United States

  • Vince Lombardi Cancer Clinic-Two Rivers

    Two Rivers, Wisconsin, 54241, United States

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157, United States

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • WellSpan Health-York Hospital

    York, Pennsylvania, 17403, United States

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007, United States

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506, United States

  • William Beaumont Hospital - Troy

    Troy, Michigan, 48085, United States

  • William Beaumont Hospital-Royal Oak

    Royal Oak, Michigan, 48073, United States

  • Yale University

    New Haven, Connecticut, 06520, United States

  • Yale-New Haven Hospital North Haven Medical Center

    North Haven, Connecticut, 06473, United States

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