Clinical trial · Interventional
Screening Contrast-Enhanced Mammography as an Alternative to MRI
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast-enhanced mammography | Device | — | UNRESOLVED |
| Iodinated Contrast Media (ICM) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Contrast-enhanced mammography
- description
- 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.
- interventionNames
- Device: Contrast-enhanced mammography
- Drug: Iodinated Contrast Media (ICM)
Primary outcomes (1)
- measure
- Cancer Detection Rate (CDR) Per 1,000 Screenings
- timeFrame
- 1.5 years
- description
- Cancer detection rate per 1,000 screenings with CEM compared to standard mammography/tomosynthesis (DBT) alone. Interpretation and performance outcomes from the primary reader were compared between standard-of-care DBT examinations interpreted alone and DBT examinations interpreted with the addition of CEM.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Asymptomatic women under age 75 who are recommended for annual screening MRI and mammography based on current criteria: 1. 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. 2. Women with extremely dense breasts age 40-75 (about 7% of the screening population (1)) (12). 2. Women with lobular carcinoma in situ (1% of women biopsied each year; about 0.06% of our screening population) beginning the year after diagnosis. 3. 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). 4. 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. Exclusion Criteria: 1. Under age 30 or over age 75. 2. Pregnant or breast feeding. 3. Breast implants. 4. Breast surgery within the prior 12 months. 5. Breast signs or symptoms (lump, nipple discharge, nipple retraction, or being followed for breast abnormality on prior imaging). 6. Currently undergoing any type of systemic chemotherapy for cancer (excludes oral endocrine therapy such as aromatase inhibitors or tamoxifen). 7. Reduced kidney function with eGFR \< 45 mL/min.
References
Publications (1)
- DERIVEDBerg 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