Screening Contrast-Enhanced Mammography as an Alternative to MRI

NCT04764292 | Completed Phase 4 FDA Drug FDA Device

• 1 other identifier: STUDY20110029
• Study Type: interventional
• Target: 601
• Locations: 1 country
• Sites: 3

Brief Summary

There are women for whom a screening breast MRI is clinically recommended, but not feasible either due to patient factors (body habitus, pacemaker or other implant, claustrophobia) or access (cost, other constraints). Contrast-enhanced mammography (CEM) is a potential alternative to MRI for screening that uses updated standard mammography equipment to obtain low- and high-energy images after intravenous injection of iodinated contrast (as used in CT scanning). The investigators seek to validate screening CEM as an alternative to screening MRI.

Conditions

Breast Cancer

Keywords

breast cancer supplemental screening; breast density; contrast-enhanced mammography; screening mammography

Outcome Measures

Primary Outcomes (1)

• Cancer Detection Rate

  To show significantly improved cancer detection with CEM compared to standard mammography/tomosynthesis

  1.5 years

Secondary Outcomes (1)

• False Positive Recall Rates

  1.5 years

Study Arms (1)

Contrast-enhanced mammography

EXPERIMENTAL

Women who meet criteria for supplemental screening MRI, but who are unable to have MRI for medical/access/cost reasons, will be invited to have screening with contrast-enhanced mammography. Women will also have standard-of-care mammography/tomosynthesis per usual clinical practice.

Device: Contrast-enhanced mammography; Drug: Iodinated Contrast Media (ICM)

Interventions

Contrast-enhanced mammography DEVICE

supplemental breast cancer screening with contrast-enhanced mammography

Contrast-enhanced mammography

Iodinated Contrast Media (ICM) DRUG

supplemental breast cancer screening with contrast-enhanced mammography

Contrast-enhanced mammography

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Asymptomatic women under age 75 who are recommended for annual screening MRI and mammography based on current criteria:
• Women known to be at high risk for breast cancer because of known or suspected pathogenic mutation, prior chest radiation therapy at least 8 years earlier and before age 30, or estimated lifetime risk of at least 20% based on family history/prior biopsy history (22), between age 30 and 75.
• Women with extremely dense breasts age 40-75 (about 7% of the screening population (1)) (12).
• Women with lobular carcinoma in situ (1% of women biopsied each year; about 0.06% of our screening population) beginning the year after diagnosis.
• Women with a personal history of breast cancer diagnosed by age 50 or with dense breasts (21), beginning the year after diagnosis (will be recruited under separate ongoing TOCEM protocol).
• Women with heterogeneously dense breasts and any family history of breast cancer (about 36% of the screening population has dense breasts and about 20% have a family history of breast cancer) who do not meet current high-risk criteria, beginning at age 40 or ten years prior to the age of the youngest relative but not before age 30.
• Participants are expected to have medical or other reasons that they are not able to have screening breast MRI.

You may not qualify if:

• Under age 30 or over age 75.
• Pregnant or breast feeding.
• Breast implants.
• Breast surgery within the prior 12 months.
• Breast signs or symptoms (lump, nipple discharge, nipple retraction, or being followed for breast abnormality on prior imaging).
• Currently undergoing any type of systemic chemotherapy for cancer (excludes oral endocrine therapy such as aromatase inhibitors or tamoxifen).
• Reduced kidney function with eGFR \< 45 mL/min.

Sponsors & Collaborators

• Wendie Berg: lead
• PA Breast Cancer Coalition: collaborator

Study Sites (3)

UPMC Magee at the Lemieux Sports Complex

Cranberry Township, Pennsylvania, 16066, United States

Location

UPMC Magee Monroeville Breast Care Center

Pittsburgh, Pennsylvania, 15146, United States

Location

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Berg WA, Vargo A, Lu AH, Berg JM, Bandos AI, Hartman JY, Zuley ML, Ganott MA, Kelly AE, Nair BE, Chough DM, Reginella RF, Wallace LP, Harnist KS, Carlin BA, Cohen CS, Hakim CM, Sumkin JH. Screening for Breast Cancer with Contrast-enhanced Mammography as an Alternative to MRI: SCEMAM Trial Results. Radiology. 2025 Jun;315(3):e242634. doi: 10.1148/radiol.242634.

  PMID: 40525975 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Wendie Berg, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Radiology, Breast Imaging Division

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 21, 2021
• Study Start: February 15, 2021
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: after publication
• Access Criteria: secondary investigators for image analysis. Sharing via Box

Locations

US (3)