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

NCT02933489 | Active Not Recruiting Results DMC FDA Device

• 5 other identifiers: EA1141NCI-2016-00252s16-01825ECOG-ACRIN-EA1141UG1CA189828
• Study Type: interventional
• Target: 1,516
• Locations: 2 countries
• Sites: 68

Brief 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.

Conditions

Asymptomatic

Outcome Measures

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 (%).

  Up to 1 year

Secondary Outcomes (9)

• Positive Predictive Value (PPV) of Biopsies

  Baseline to up to 1 year

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

  Baseline

• Prediction of Breast Cancer (Sensitivity and Specificity)

  Baseline to up to 1 year

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

  Baseline to up to 1 year

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

  Up to 1 year

Study Arms (2)

Arm A (DBT, AB-MR)

EXPERIMENTAL

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

Arm B (AB-MR, DBT)

EXPERIMENTAL

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

Contrast-enhanced Magnetic Resonance Imaging DIAGNOSTIC_TEST

Undergo AB-MR

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

Arm A (DBT, AB-MR); Arm B (AB-MR, DBT)

Digital Tomosynthesis Mammography DIAGNOSTIC_TEST

Undergo DBT

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

Arm A (DBT, AB-MR); Arm B (AB-MR, DBT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm A (DBT, AB-MR); Arm B (AB-MR, DBT)

Questionnaire Administration OTHER

Ancillary studies

Arm A (DBT, AB-MR); Arm B (AB-MR, DBT)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• ECOG-ACRIN Cancer Research Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (68)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

Huntington Memorial Hospital

Pasadena, California, 91105, United States

Location

The Women's Imaging Center

Denver, Colorado, 80209, United States

Location

Radiology Imaging Associates

Englewood, Colorado, 80112, United States

Location

Norwalk Hospital

Norwalk, Connecticut, 06856, United States

Location

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Boca Raton Regional Hospital

Boca Raton, Florida, 33486, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Diagnostic Center for Women LLC

Miami, Florida, 33173, United States

Location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, 60201, United States

Location

Clinical Radiologists SC

Springfield, Illinois, 62781, United States

Location

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

The Community Hospital

Munster, Indiana, 46321, United States

Location

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States

Location

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

Location

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States

Location

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States

Location

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Mercy Health Saint Mary's

Grand Rapids, Michigan, 49503, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

Essentia Health Cancer Center

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Riverview Medical Center/Booker Cancer Center

Red Bank, New Jersey, 07701, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Montefiore Medical Center-Einstein Campus

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center - Moses Campus

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

Location

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

Location

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Aultman Health Foundation

Canton, Ohio, 44710, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

UHHS-Westlake Medical Center

Westlake, Ohio, 44145, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

ECOG-ACRIN Cancer Research Group

Philadelphia, Pennsylvania, 19103, United States

Location

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Vanderbilt Breast Center at One Hundred Oaks

Nashville, Tennessee, 37204, United States

Location

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Farmington Health Center

Farmington, Utah, 84025, United States

Location

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

South Jordan Health Center

South Jordan, Utah, 84009, United States

Location

Sentara Martha Jefferson Hospital

Charlottesville, Virginia, 22901, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

Sentara Leigh Hospital

Norfolk, Virginia, 23502, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911, United States

Location

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, 53149, United States

Location

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066, United States

Location

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, 53188, United States

Location

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188, United States

Location

Rwth Klinikum Aachen

Aachen, 52074, Germany

Location

Related Publications (1)

• 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.

  PMID: 32096852 RESULT

Related Links

• Primary Manuscript

MeSH Terms

Interventions

Dynamic Contrast Enhanced Magnetic Resonance Imaging; Mammography

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography

Results Point of Contact

• Title: Director Clinical Research Administration
• Organization: ECOG-ACRIN

dhartfeil@acr.org

800-227-5463

Study Officials

• Christopher Comstock

  ECOG-ACRIN Cancer Research Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 14, 2016
• Study Start: December 27, 2016
• Primary Completion: January 23, 2020
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 25, 2026
• Results First Posted: February 5, 2021

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: With publication
• Access Criteria: All requests will require a statistical plan and justification. Approved requests will require a DUA.

Locations

DE (1); US (67)