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AsymptomaticNCT02933489

Abbreviated Breast MRI and Digital Tomosynthesis Mammography in Screening Women With Dense Breasts

A study testing Contrast-enhanced Magnetic Resonance Imaging, Digital Tomosynthesis Mammography and Quality-of-Life Assessment in people with Asymptomatic, run by ECOG-ACRIN Cancer Research Group at 68 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This randomized phase II trial studies how well abbreviated breast magnetic resonance imaging (MRI) and digital tomosynthesis mammography work in detecting cancer in women with dense breasts. Read more about this study

Who is it for?
Ages 40 to 75 years, women onlyHealthy volunteers can take part
Conditions the study is for
Asymptomatic
What is being tested?
Contrast-enhanced Magnetic Resonance Imaging, Digital Tomosynthesis Mammography and Quality-of-Life Assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,516 participants
Where
68 sitesin 2 countries
Study dates
27 Dec 2016to 31 Dec 2026
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 22Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

68 sites in 2 countries.

68 sites in 2 countries

United States67 sites

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Sentara Martha Jefferson Hospital

    Charlottesville, Virginia, 22901

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • The Women's Imaging Center

    Denver, Colorado, 80209

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Radiology Imaging Associates

    Englewood, Colorado, 80112

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Farmington Health Center

    Farmington, Utah, 84025

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Diagnostic Center for Women LLC

    Miami, Florida, 33173

  • ProHealth D N Greenwald Center

    Mukwonago, Wisconsin, 53149

  • The Community Hospital

    Munster, Indiana, 46321

  • Vanderbilt Breast Center at One Hundred Oaks

    Nashville, Tennessee, 37204

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Sentara Leigh Hospital

    Norfolk, Virginia, 23502

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Norwalk Hospital

    Norwalk, Connecticut, 06856

  • ProHealth Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Huntington Memorial Hospital

    Pasadena, California, 91105

  • ECOG-ACRIN Cancer Research Group

    Philadelphia, Pennsylvania, 19103

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Riverview Medical Center/Booker Cancer Center

    Red Bank, New Jersey, 07701

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • South Jordan Health Center

    South Jordan, Utah, 84009

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Clinical Radiologists SC

    Springfield, Illinois, 62781

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467-2490

  • ProHealth Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • UW Cancer Center at ProHealth Care

    Waukesha, Wisconsin, 53188

  • UHHS-Westlake Medical Center

    Westlake, Ohio, 44145

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205

  • Novant Health Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

Other trials in United States

Germany1 site

  • Rwth Klinikum Aachen

    Aachen, 52074

Other trials in Germany

About this study

Official title: Comparison of Abbreviated Breast MRI and Digital Breast Tomosynthesis in Breast Cancer Screening in Women With Dense Breasts

This randomized phase II trial studies how well abbreviated breast magnetic resonance imaging (MRI) and digital tomosynthesis mammography work in detecting cancer in women with dense breasts. Abbreviated breast MRI is a low cost procedure in which radio waves and a powerful magnet linked to a computer and used to create detailed pictures of the breast in less than 10 minutes. These pictures can show the difference between normal and diseased tissue. Digital tomosynthesis mammography is a procedure that uses multiple x-rays pictures of each breast to produce a 3-dimensional rendering of the entire breast. Combined screening with abbreviated breast MRI and digital tomosynthesis mammography may be a better method to screen women with dense breasts.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To compare the rates of detection of invasive cancers between the initial abbreviated breast (AB)-magnetic resonance (MR) and digital tomosynthesis mammography (DBT).

SECONDARY OBJECTIVES:

  1. To compare the positive predictive value (PPV) of biopsies, call back rates, and short-term follow up rates after AB-MR and DBT on both the initial and 1 year follow up studies.

II. To estimate and compare the sensitivity and specificity of AB-MR and DBT, using the 1 year follow up to define a reference standard.

III. To compare patient-reported short-term quality of life related to diagnostic testing with AB-MR and DBT using the Testing Morbidities Index.

IV. To compare willingness to return for testing with AB-MRI versus (vs) DBT within the recommended screening interval and explore factors associated with willingness to return for screening.

  1. To compare the tumor biologies of invasive cancers and ductal carcinoma in situ (DCIS) detected on AB-MR and DBT.

VI. To estimate the incident cancer rate during 3 years following the year-1 AB-MR/DBT when patients return to standard screening.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM A (DBT, AB-MR): Participants undergo DBT followed by AB-MR for under 10 minutes on the same day or within 24 hours at baseline and then after 1 year.

ARM B (AB-MR, DBT): Participants undergo AB-MR for under 10 minutes followed by DBT on the same day or within 24 hours at baseline and then after 1 year.

After completion of study, patients are followed up at every 6 months for 3 years.

Conditions
Asymptomatic
Being tested
Contrast-enhanced Magnetic Resonance Imaging, Digital Tomosynthesis Mammography, Quality-of-Life Assessment, Questionnaire Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Contrast-enhanced Magnetic Resonance ImagingDiagnostic test

    Also called CONTRAST ENHANCED MRI, Contrast-enhanced MRI

    Undergo AB-MR

  • Digital Tomosynthesis MammographyDiagnostic test

    Also called DBT, Digital Breast Tomosynthesis, Digital Tomosynthesis of the Breast

    Undergo DBT

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT02933489
Study groupRoleWhat they receive
Arm A (DBT, AB-MR)ExperimentalParticipants undergo DBT followed by AB-MR for under 10 minutes on the same day or within 24 hours at baseline and then after 1 year.
Receives: Diagnostic Test: Contrast-enhanced Magnetic Resonance Imaging; Diagnostic Test: Digital Tomosynthesis Mammography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm B (AB-MR, DBT)ExperimentalParticipants undergo AB-MR for under 10 minutes followed by DBT on the same day or within 24 hours at baseline and then after 1year.
Receives: Diagnostic Test: Contrast-enhanced Magnetic Resonance Imaging; Diagnostic Test: Digital Tomosynthesis Mammography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Screen-detected Invasive Cancer Verified by Pathology

    For each modality, the detection rate of invasive cancers is defined as the proportion of participants who had an invasive cancer detected by the modality at baseline and verified by pathology versus the total number of participants. In the out come measures table below, these proportions will be automatically calculated, multiplied by 100, and be presented as percentages (%).

    Measured: Up to 1 year

Secondary outcomes (9)

  1. Positive Predictive Value (PPV) of Biopsies

    Test Positive (T+): Biopsy recommended by imaging, defined as patients with at least one lesion rated BI-RADS 4 or 5 on image interpretation. Reference Standard Positive (RS+): Pathologically confirmed DCIS or invasive disease resultant from a positive test.

    The 95% confidence interval for PPV of biopsy for each modality were derived from the GEE model using the appropriate estimable contrasts with robust standard errors

    Measured: Baseline to up to 1 year

  2. Call Back/Additional Imaging/Short-term Follow Rates for DBT and AB-MR

    For DBT:

    DBT: Call back is defined as having additional views or targeted ultrasound to evaluate DBT findings DBT: short term follow up (STFU) is defined as having at least one lesion rated BI-RADS 3 on DBT DBT: Additional imaging recommendation is defined as having either call back or STFU

    For AB-MR:

    Ab-MR: Call back does not apply to AB-MR and will not be evaluated Ab-MR: Short Term Follow-up (STFU) is defined as having at least one lesion rated BI-RADS 3 on AB-MR Ab-MR: Additional imaging recommendation is defined as having a STFU

    Measured: Baseline

  3. Prediction of Breast Cancer (Sensitivity and Specificity)

    Reference standard positive (RS+): breast cancer (invasive or DCIS) detected on the year 0 screening or reported at any time from the year 0 to the year 1 screening.

    Reference standard negative (RS-): No breast cancer reported at any time from the year 0 to the year 1 screen.

    Incomplete: No Year 1 imaging, and <11 months of patient follow-up (<330 days) after year 0 screen

    Positive Test (T+) is defined as the imaging modality result is positive (BI-RADS 3-5), and the location of the finding is matches the location of the cancer indicated by the reference standard.

    Negative Test (T-) will be estimated as the fraction of reference standard negative subjects for whom the imaging modality result was negative (BI-RADS 1-2).

    95% confidence intervals for the sensitivity and specificity of each modality calculated using the Wilson method.

    Measured: Baseline to up to 1 year

  4. Change in Patient-reported Short-term Quality of Life Related to Diagnostic Testing

    Testing Morbidities Index (TMI) scores [0 (worst) to 100 (best) scale] will be computed for abbreviated breast-magnetic resonance (MR) and digital tomosynthesis mammography (DBT) after the baseline screen.

    Measured: Baseline to up to 1 year

  5. Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT)

    The proportions of participants willing to return for screening with either test, AB-MRI only, DBT only, or not willing to return for either test will be estimated.

    Measured: Up to 1 year

  6. Factors Associated With Willingness to Return for Screening

    Polytomous logistic regression will be used to examine factors associated with willingness to return, including screen result, cancer status, and demographic characteristics.

    Measured: Up to 1 year

  7. Oncotype-DCIS Scores by Modality

    Descriptive Analyses presenting the the distributions of Oncotype-DCIS scores by modality: Ductal carcinoma in situ (DCIS) detected on abbreviated breast-magnetic resonance (MR) and digital tomosynthesis mammography (DBT) A low risk score is less than 39, and a high risk score is 55 or higher. A score of 39 to 54 is intermediate risk.

    Measured: Up to 1 year

  8. Incident Cancer Rate

    Breast cancer incidence will be estimated. Person-years will be measured.

    Measured: Up to 3 years

  9. NanoString Tumor Biologies of Invasive Cancers and Ductal Carcinoma in Situ (DCIS) Detected on AB-MR and DBT

    For all invasive cancers detected during the study period, the NanoString PAM50 will be performed. The frequencies of cancer types determined by the NanoString analysis will be tabulated and compared. For DCIS, if the Oncotype-DCIS score was performed, the distributions of scores will be tabulated and compared.

    All efforts to obtain NanoString data have been exhausted, therefore we have no data available to report.

    Measured: end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2016 (estimated)
  2. Study start27 Dec 2016
  3. Primary completion23 Jan 2020
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,516 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02933489
Sponsor's protocol ID
EA1141
Other IDs
NCI-2016-00252, s16-01825, EA1141, ECOG-ACRIN-EA1141, EA1141, UG1CA189828
Status last verified
Feb 2026
First submitted
12 Oct 2016
Last updated
25 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Safe harbor de-identified data corresponding to publications will be shared upon request

Publications

  • Comstock CE, Gatsonis C, Newstead GM, Snyder BS, Gareen IF, Bergin JT, Rahbar H, Sung JS, Jacobs C, Harvey JA, Nicholson MH, Ward RC, Holt J, Prather A, Miller KD, Schnall MD, Kuhl CK. Comparison of Abbreviated Breast MRI vs Digital Breast Tomosynthesis for Breast Cancer Detection Among Women With Dense Breasts Undergoing Screening. JAMA. 2020 Feb 25;323(8):746-756. doi: 10.1001/jama.2020.0572.

    PubMed 32096852

Questions about this trial

What is this clinical trial studying?

A study testing Contrast-enhanced Magnetic Resonance Imaging, Digital Tomosynthesis Mammography and Quality-of-Life Assessment in people with Asymptomatic, run by ECOG-ACRIN Cancer Research Group at 68 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Screen-detected Invasive Cancer Verified by Pathology (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02933489, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.

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