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Active, not recruitingNCT02933489Updated Feb 25, 2026Results posted

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

An interventional study of Contrast-enhanced Magnetic Resonance Imaging and Digital Tomosynthesis Mammography in Asymptomatic, sponsored by ECOG-ACRIN Cancer Research Group. Active, not recruiting at 68 sites in 2 countries. Open to female participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-25.

Sponsored by ECOG-ACRIN Cancer Research Group · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
1,516
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
Female
01

Study 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. 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:

I. 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:

I. 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.

V. 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.

02

Conditions studied

  • Asymptomatic
03

In context

Lead sponsor

ECOG-ACRIN Cancer Research Group is the lead sponsor of 118 studies on the registry; 13 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 13 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,516 participants (actual)

Study arms

  • Experimental
    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.

    Diagnostic Test: Contrast-enhanced Magnetic Resonance Imaging · Diagnostic Test: Digital Tomosynthesis Mammography · Other: Quality-of-Life Assessment · Other: Questionnaire Administration

  • Experimental
    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 1year.

    Diagnostic Test: Contrast-enhanced Magnetic Resonance Imaging · Diagnostic Test: Digital Tomosynthesis Mammography · Other: Quality-of-Life Assessment · Other: Questionnaire Administration

Interventions

  • Diagnostic testContrast-enhanced Magnetic Resonance Imaging

    Undergo AB-MR

    Also known as: CONTRAST ENHANCED MRI, Contrast-enhanced MRI

  • Diagnostic testDigital Tomosynthesis Mammography

    Undergo DBT

    Also known as: DBT, Digital Breast Tomosynthesis, Digital Tomosynthesis of the Breast

  • OtherQuality-of-Life Assessment

    Ancillary studies

    Also known as: Quality of Life Assessment

  • OtherQuestionnaire Administration

    Ancillary studies

06

What researchers measure

Primary outcomes

  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 (%).

    Time frame: Up to 1 year

Secondary outcomes

  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

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Up to 1 year

  8. Incident Cancer Rate

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

    Time frame: 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.

    Time frame: end of study

07

Results

Posted Feb 5, 2021

Participant flow

Women with dense breasts scheduled for routine screening with DBT were enrolled to receive DBT and AB-MR, with scan order determined by randomization. The first subject was accrued on December 27, 2016, and accrual ended on November 10, 2017. A total of 48 institutions participated.

Participant flow — Overall Study
MilestoneArm A (DBT, AB-MR)Arm B (AB-MR, DBT)
Started757759
Dbtperformed726737
Ab mr performed713733
Dcis detected56
Pam50 nanostring00
Completed713731
Not completed4428
Withdrew: Ineligible33
Withdrew: Withdrawal by subject2718
Withdrew: Unable to complete exams (other)147

Outcome measures

PrimaryScreen-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 (%).

Time frame:
Up to 1 year
Reported as:
Count of participants · Participants
Screen-detected Invasive Cancer Verified by Pathology
ParticipantsDigital Breast Tomosynthesis (DBT)Abbreviated Breast MR (AB-MR)
No Invasive Cancer Detected14371427
Invasive Cancer Detected717
Statistical analysis
  • Digital Breast Tomosynthesis (DBT) vs Abbreviated Breast MR (AB-MR) · McNemar · p = 0.002 · Wald interval with bonett-price laplace: 0.007 · 95% CI 0.0022 to 0.0116Wald interval with Bonett-Price Laplace, described in : Fagerland MW, Lydersen S, Laake P. Recommended tests and confidence intervals for paired binomial proportions. Statist. Med. 2014; 33:2850-75.
SecondaryPositive 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

Time frame:
Baseline to up to 1 year
Reported as:
Number · percentage of Biopsy Recommended
Positive Predictive Value (PPV) of Biopsies
percentage of Biopsy RecommendedBiopsy Recommended by Digital Breast TomographyBiopsy Recommended by AB-MR
Positive Predictive Value (PPV) of Biopsies31.0 (17.0 to 49.7)19.6 (13.2 to 28.2)
Statistical analysis
  • Biopsy Recommended by Digital Breast Tomography vs Biopsy Recommended by AB-MR · Leisenring · p = 0.15 (Generalized estimating equation (GEE) regression with the p-value from the resulting score test. 5 secondary comparisons were planned: alpha level of 0.05/5 = 0.01 for p-value significance)Leisenring W, Alonzo T, Pepe MS. Comparisons of predictive values of binary medical diagnostic tests for paired designs. Biometrics. 2000;56:345-351
SecondaryCall 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

Time frame:
Baseline
Reported as:
Count of participants · Participants
Call Back/Additional Imaging/Short-term Follow Rates for DBT and AB-MR
ParticipantsDBT Additional Imaging RecommendationAB-MR Additional Imaging Recommendation
Call back146NA
Short-term follow-up (subject-level)18108
Additional imaging recommendation146108
Statistical analysis
  • DBT Additional Imaging Recommendation vs AB-MR Additional Imaging Recommendation · McNemar · p = <0.0001 (To adjust for multiplicity, using the Bonferroni correction, secondary comparisons are compared against an adjusted alpha level of 0.05/5=0.01 corresponding to the 5 secondary comparisons outlined in the Statistical Analysis Plan (SAP))exact p-value
  • DBT Additional Imaging Recommendation vs AB-MR Additional Imaging Recommendation · McNemar · p = 0.02 (To adjust for multiplicity, using the Bonferroni correction, secondary comparisons are compared against an adjusted alpha level of 0.05/5 = 0.01, corresponding to the 5 secondary comparisons outlined in the SAP)exact p-values
SecondaryPrediction 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.

Time frame:
Baseline to up to 1 year
Reported as:
Number · percentage of correct classifications
Prediction of Breast Cancer (Sensitivity and Specificity)
percentage of correct classificationsTest A: Digital Breast TomographyTest B: Abbreviated MR
Sensitivity (T+|RS+)39.1 (22.2 to 59.2)95.7 (79.0 to 99.2)
Specificity (T-|RS-)97.4 (96.5 to 98.1)86.7 (84.8 to 88.4)
Statistical analysis
  • Test A: Digital Breast Tomography vs Test B: Abbreviated MR · McNemar · p = 0.001 (The comparison of the sensitivity of AB-MR and DBT uses a two-sided exact McNemar's test to account for the paired design 5 secondary comparisons were planned: alpha level of 0.05/5 = 0.01 for p-value significance)
  • Test A: Digital Breast Tomography vs Test B: Abbreviated MR · McNemar · p = <0.001 (The comparison of the Specificity of AB-MR and DBT uses a two-sided exact McNemar's test to account for the paired design 5 secondary comparisons were planned: alpha level of 0.05/5 = 0.01 for p-value significance)
SecondaryChange 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.

Time frame:
Baseline to up to 1 year
Reported as:
Mean · score on 0-100 scale
Change in Patient-reported Short-term Quality of Life Related to Diagnostic Testing
score on 0-100 scaleAbbreviated MRIDigital Breast Tomosynthesis
TMI component during exam90.1 (89.5 to 90.7)86.3 (85.6 to 86.9)
TMI component after exam98.4 (98.0 to 98.7)99.0 (98.7 to 99.3)
SecondaryWillingness 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.

Time frame:
Up to 1 year
Reported as:
Count of participants · Participants
Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT)
ParticipantsAbbreviated MRI Willingness to be Screened in the FutureDigital Breast Tomosynthesis Willingness to be Screened in the FutureAb-MRI Future Screen if AB-MRI Detects More Cancer Than Mammography or UltrasoundDBT Future Screen if DBT Detects More Cancer Than Mammography or Ultrasound
Screen every year1107122112371271
Screen every two years147666435
Screen every three years341373
Screen every four Years13544
Never Again13875
SecondaryFactors 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.

Time frame:
Up to 1 year

Results for this outcome have not been posted.

SecondaryOncotype-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.

Time frame:
Up to 1 year
Reported as:
Count of participants · Participants
Oncotype-DCIS Scores by Modality
ParticipantsDigital Breast Tomosynthesis (DBT) Oncotype DX for DCISAbbreviated Breast MR (AB-MR) Oncotype DX for DCIS
Low (<39)12
Intermediate (39-54)01
High risk (>54)00
Tissue not available/not submitted43
DCIS not detected by Modality54
SecondaryIncident Cancer Rate

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

Time frame:
Up to 3 years
Reported as:
Number · cancers per 1,000 person-years
Incident Cancer Rate
cancers per 1,000 person-yearsAll Participants
Year 1 Screen to 12 mo post screening7.89 (3.79 to 14.52)
12 months to 24 months post study screening3.19 (0.87 to 8.18)
24 months to 36 months study screening5.00 (1.84 to 10.89)
SecondaryNanoString 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.

Time frame:
end of study

No measurements were reported for this outcome.

Adverse events

Collected over 1 year for Adverse Events and All deaths while on-study. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
All Participants6/1,444 (0.4%)6/1,444 (0.4%)25/1,444 (1.7%)
Most frequent serious events
Most frequent serious events
EventAll Participants
Death NOSGeneral disorders3/1444
Disease progressionGeneral disorders1/1444
Malignant neoplasm of the right lungNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1444
Intracranial hemorrhageNervous system disorders1/1444
Respiratory failureRespiratory, thoracic and mediastinal disorders1/1444
Most frequent other events
Showing 10 of 20
Most frequent other events
EventAll Participants
NauseaGastrointestinal disorders2/1444
Allergic reactionImmune system disorders2/1444
Vascular access complicationInjury, poisoning and procedural complications2/1444
Vasovagal reactionNervous system disorders2/1444
AnxietyPsychiatric disorders2/1444
VertigoEar and labyrinth disorders1/1444
Bilateral Eye swellingEye disorders1/1444
VomitingGastrointestinal disorders1/1444
Facial rashGeneral disorders1/1444
Infusion site extravasationGeneral disorders1/1444

Baseline characteristics

Age, Continuous
Age, Continuous(years)Arm A (DBT, AB-MR)Arm B (AB-MR, DBT)Total
Mean54.9 ± 8.754.9 ± 8.454.9 ± 8.6
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Arm A (DBT, AB-MR)Arm B (AB-MR, DBT)Total
Female7577591516
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm A (DBT, AB-MR)Arm B (AB-MR, DBT)Total
Hispanic or Latino113142
Not Hispanic or Latino7046781382
Unknown or Not Reported425092
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm A (DBT, AB-MR)Arm B (AB-MR, DBT)Total
American Indian or Alaska Native033
Asian382260
Native Hawaiian or Other Pacific Islander112
Black or African American294170
White6486391287
More than one race000
Unknown or Not Reported415394
Menopausal Status
Menopausal Status(Participants)Arm A (DBT, AB-MR)Arm B (AB-MR, DBT)Total
Pre-menopausal236206442
Peri-menopausal494594
Naturally post-menopausal316355671
Surgically post-menopausal114129243
Unknown (data not available)422466
Breast density (baseline DBT)
Breast density (baseline DBT)(Participants)Arm A (DBT, AB-MR)Arm B (AB-MR, DBT)Total
Almost entirely fat112
Scattered fibroglandular densities5066116
Heterogeneously dense5645641128
Extremely dense113109222
Scan not performed291948
Prior personal history of breast cancer
Prior personal history of breast cancer(Participants)Arm A (DBT, AB-MR)Arm B (AB-MR, DBT)Total
No7247281452
Yes369
Unknown302555
08

Study locations

68 sites
  • Banner MD Anderson Cancer Center
    Gilbert, Arizona 85234, United States
  • Huntington Memorial Hospital
    Pasadena, California 91105, United States
  • The Women's Imaging Center
    Denver, Colorado 80209, United States
  • Radiology Imaging Associates
    Englewood, Colorado 80112, United States
  • Norwalk Hospital
    Norwalk, Connecticut 06856, United States
  • Helen F Graham Cancer Center
    Newark, Delaware 19713, United States
  • Boca Raton Regional Hospital
    Boca Raton, Florida 33486, United States
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224-9980, United States
  • Diagnostic Center for Women LLC
    Miami, Florida 33173, United States
  • Emory University Hospital/Winship Cancer Institute
    Atlanta, Georgia 30322, United States
  • Queen's Medical Center
    Honolulu, Hawaii 96813, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • University of Chicago Comprehensive Cancer Center
    Chicago, Illinois 60637, United States
  • NorthShore University HealthSystem-Evanston Hospital
    Evanston, Illinois 60201, United States
  • Clinical Radiologists SC
    Springfield, Illinois 62781, United States
  • Indiana University/Melvin and Bren Simon Cancer Center
    Indianapolis, Indiana 46202, United States
  • The Community Hospital
    Munster, Indiana 46321, United States
  • Oncology Associates at Mercy Medical Center
    Cedar Rapids, Iowa 52403, 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
  • Ochsner Medical Center Jefferson
    New Orleans, Louisiana 70121, United States
  • Johns Hopkins University/Sidney Kimmel Cancer Center
    Baltimore, Maryland 21287, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • Lahey Hospital and Medical Center
    Burlington, Massachusetts 01805, United States
  • Mercy Health Saint Mary's
    Grand Rapids, Michigan 49503, United States
  • West Michigan Cancer Center
    Kalamazoo, Michigan 49007, United States
  • Essentia Health Cancer Center
    Duluth, Minnesota 55805, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Washington University School of Medicine
    St Louis, Missouri 63110, 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
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone
    New York, New York 10016, United States
  • Memorial Sloan-Kettering Cancer Center
    New York, New York 10065, United States
  • Montefiore Medical Center-Einstein Campus
    The Bronx, New York 10461, United States
  • Montefiore Medical Center - Moses Campus
    The Bronx, New York 10467-2490, United States
  • Carolinas Medical Center/Levine Cancer Institute
    Charlotte, North Carolina 28203, United States
  • Novant Health Forsyth Medical Center
    Winston-Salem, North Carolina 27103, United States
  • Aultman Health Foundation
    Canton, Ohio 44710, United States
  • Case Western Reserve University
    Cleveland, Ohio 44106, United States
  • UHHS-Westlake Medical Center
    Westlake, Ohio 44145, United States
  • University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma 73104, United States
  • Geisinger Medical Center
    Danville, Pennsylvania 17822, United States
  • Penn State Milton S Hershey Medical Center
    Hershey, Pennsylvania 17033-0850, United States
  • ECOG-ACRIN Cancer Research Group
    Philadelphia, Pennsylvania 19103, United States
  • University of Pennsylvania/Abramson Cancer Center
    Philadelphia, Pennsylvania 19104, United States
  • Rhode Island Hospital
    Providence, Rhode Island 02903, United States
  • Spartanburg Medical Center
    Spartanburg, South Carolina 29303, United States
  • Vanderbilt Breast Center at One Hundred Oaks
    Nashville, Tennessee 37204, United States
  • Vanderbilt University/Ingram Cancer Center
    Nashville, Tennessee 37232, United States
  • Baylor University Medical Center
    Dallas, Texas 75246, United States
  • Farmington Health Center
    Farmington, Utah 84025, United States
  • Huntsman Cancer Institute/University of Utah
    Salt Lake City, Utah 84112, United States
  • South Jordan Health Center
    South Jordan, Utah 84009, United States
  • Sentara Martha Jefferson Hospital
    Charlottesville, Virginia 22901, United States
  • University of Virginia Cancer Center
    Charlottesville, Virginia 22908, United States
  • Sentara Leigh Hospital
    Norfolk, Virginia 23502, United States
  • Sentara Norfolk General Hospital
    Norfolk, Virginia 23507, United States
  • Fred Hutchinson Cancer Research Center
    Seattle, Washington 98109, United States
  • Seattle Cancer Care Alliance
    Seattle, Washington 98109, United States
  • University of Washington Medical Center
    Seattle, Washington 98195, United States
  • ThedaCare Regional Cancer Center
    Appleton, Wisconsin 54911, United States
  • Gundersen Lutheran Medical Center
    La Crosse, Wisconsin 54601, United States
  • University of Wisconsin Hospital and Clinics
    Madison, Wisconsin 53792, 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
  • UW Cancer Center at ProHealth Care
    Waukesha, Wisconsin 53188, United States
  • Rwth Klinikum Aachen
    Aachen, 52074, Germany
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References and documents

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 ↗

Study documents

  • Protocol and statistical analysis plan · Oct 10, 2019
  • Informed consent form · Feb 26, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Safe harbor de-identified data corresponding to publications will be shared upon request

Supporting information: Study protocol, Sap

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02933489
Lead sponsor
ECOG-ACRIN Cancer Research Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Oct 14, 2016
Start date
Dec 27, 2016
Primary completion
Jan 23, 2020
Completion
Dec 31, 2026 (estimated)
Results posted
Feb 5, 2021
Last update
Feb 25, 2026

Study contacts

Christopher Comstock
principal investigator · ECOG-ACRIN Cancer Research Group

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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