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Active, not recruiting Not applicable

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

NCT02933489 · tracked via the Priya Life Science Israel tracker
Phase
Not applicable
Started
2016-12-27
Last updated
2026-02-25

Condition(s) studied

Asymptomatic

Investigational drug(s) / intervention(s)

Contrast-enhanced Magnetic Resonance ImagingDigital Tomosynthesis MammographyQuality-of-Life AssessmentQuestionnaire Administration

Contrast-enhanced Magnetic Resonance Imaging: Undergo AB-MR

Digital Tomosynthesis Mammography: Undergo DBT

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

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.

Eligibility

Sex
FEMALE
Min age
40 Years
Max age
75 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Screen-detected Invasive Cancer Verified by Pathology — Up to 1 year
    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 (%).

Trial sites (68)

FacilityCityRegionStatus
Banner MD Anderson Cancer Center Gilbert Arizona
Huntington Memorial Hospital Pasadena California
The Women's Imaging Center Denver Colorado
Radiology Imaging Associates Englewood Colorado
Norwalk Hospital Norwalk Connecticut
Helen F Graham Cancer Center Newark Delaware
Boca Raton Regional Hospital Boca Raton Florida
Mayo Clinic in Florida Jacksonville Florida
Diagnostic Center for Women LLC Miami Florida
Emory University Hospital/Winship Cancer Institute Atlanta Georgia
Queen's Medical Center Honolulu Hawaii
Northwestern University Chicago Illinois
University of Chicago Comprehensive Cancer Center Chicago Illinois
NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
Clinical Radiologists SC Springfield Illinois
Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
The Community Hospital Munster Indiana
Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
University of Kansas Cancer Center Kansas City Kansas
University of Kansas Hospital-Westwood Cancer Center Westwood Kansas
Ochsner Medical Center Jefferson New Orleans Louisiana
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland
Beth Israel Deaconess Medical Center Boston Massachusetts
Lahey Hospital and Medical Center Burlington Massachusetts
Mercy Health Saint Mary's Grand Rapids Michigan
West Michigan Cancer Center Kalamazoo Michigan
Essentia Health Cancer Center Duluth Minnesota
Mayo Clinic Rochester Minnesota
Washington University School of Medicine St Louis Missouri
Riverview Medical Center/Booker Cancer Center Red Bank New Jersey
Roswell Park Cancer Institute Buffalo New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York
Memorial Sloan-Kettering Cancer Center New York New York
Montefiore Medical Center-Einstein Campus The Bronx New York
Montefiore Medical Center - Moses Campus The Bronx New York
Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina
Novant Health Forsyth Medical Center Winston-Salem North Carolina
Aultman Health Foundation Canton Ohio
Case Western Reserve University Cleveland Ohio
UHHS-Westlake Medical Center Westlake Ohio

+ 28 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02933489 on ClinicalTrials.gov ↗ ← All trials in Israel