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

Running, not enrolling · Not applicable

Conditions studied: Asymptomatic

In brief

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.

Key facts

Study ID

NCT02933489

Run by

ECOG-ACRIN Cancer Research Group

People needed

1516

Starts

2016-12-27

Expected to finish

2026-12-31

Last updated by the study team

2026-02-25

Who can join

Age: 40 and older, up to 75. Sex: female. Healthy volunteers: accepted.

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
• 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

Where it is running

• 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
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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