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

NCT ID: NCT02933489

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1516 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-27
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Asymptomatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Contrast-enhanced Magnetic Resonance Imaging

Intervention Type: DIAGNOSTIC_TEST

Undergo AB-MR

Digital Tomosynthesis Mammography

Intervention Type: DIAGNOSTIC_TEST

Undergo DBT

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

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.

Group Type: EXPERIMENTAL

Contrast-enhanced Magnetic Resonance Imaging

Intervention Type: DIAGNOSTIC_TEST

Undergo AB-MR

Digital Tomosynthesis Mammography

Intervention Type: DIAGNOSTIC_TEST

Undergo DBT

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Contrast-enhanced Magnetic Resonance Imaging

Undergo AB-MR

Intervention Type: DIAGNOSTIC_TEST

Digital Tomosynthesis Mammography

Undergo DBT

Intervention Type: DIAGNOSTIC_TEST

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

CONTRAST ENHANCED MRI; Contrast-enhanced MRI; DBT; Digital Breast Tomosynthesis; Digital Tomosynthesis of the Breast; Quality of Life Assessment

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])

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

ECOG-ACRIN Cancer Research Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Comstock

Role: PRINCIPAL_INVESTIGATOR

ECOG-ACRIN Cancer Research Group

Locations

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Huntington Memorial Hospital

Pasadena, California, United States

The Women's Imaging Center

Denver, Colorado, United States

Radiology Imaging Associates

Englewood, Colorado, United States

Norwalk Hospital

Norwalk, Connecticut, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Boca Raton Regional Hospital

Boca Raton, Florida, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Diagnostic Center for Women LLC

Miami, Florida, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Queen's Medical Center

Honolulu, Hawaii, United States

Northwestern University

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

Clinical Radiologists SC

Springfield, Illinois, United States

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

The Community Hospital

Munster, Indiana, United States

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Mercy Health Saint Mary's

Grand Rapids, Michigan, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Essentia Health Cancer Center

Duluth, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Riverview Medical Center/Booker Cancer Center

Red Bank, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, United States

Aultman Health Foundation

Canton, Ohio, United States

Case Western Reserve University

Cleveland, Ohio, United States

UHHS-Westlake Medical Center

Westlake, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

ECOG-ACRIN Cancer Research Group

Philadelphia, Pennsylvania, United States

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Spartanburg Medical Center

Spartanburg, South Carolina, United States

Vanderbilt Breast Center at One Hundred Oaks

Nashville, Tennessee, United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Baylor University Medical Center

Dallas, Texas, United States

Farmington Health Center

Farmington, Utah, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

South Jordan Health Center

South Jordan, Utah, United States

Sentara Martha Jefferson Hospital

Charlottesville, Virginia, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Sentara Leigh Hospital

Norfolk, Virginia, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

University of Washington Medical Center

Seattle, Washington, United States

ThedaCare Regional Cancer Center

Appleton, Wisconsin, United States

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, United States

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, United States

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, United States

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, United States

Rwth Klinikum Aachen

Aachen, , Germany

Countries

United States; Germany

References

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.

Reference Type: RESULT

PMID: 32096852 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://pubmed.ncbi.nlm.nih.gov/32096852/

Primary Manuscript

Other Identifiers

NCI-2016-00252

Identifier Type: REGISTRY

Identifier Source: secondary_id

s16-01825

Identifier Type: OTHER

Identifier Source: secondary_id

EA1141

Identifier Type: OTHER

Identifier Source: secondary_id

ECOG-ACRIN-EA1141

Identifier Type: OTHER

Identifier Source: secondary_id

EA1141

Identifier Type: OTHER

Identifier Source: secondary_id

UG1CA189828

Identifier Type: NIH

Identifier Source: secondary_id

View Link

EA1141

Identifier Type: -

Identifier Source: org_study_id