Clinical trial · Interventional
The C-MERIT Screening Cohort: Contrast-enhanced Mammography for Breast Cancer Screening and Risk Assessment in Women With Dense Breasts
NCT05667532CI-TRIAL-00118245recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
To learn whether a new imaging technology, Contrast-Enhanced Mammography (CEM), compared to standard mammography, can better detect breast cancers in women with dense breasts
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast Enhanced Mammography | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Contrast Enhanced Mammography
- interventionNames
- Diagnostic Test: Contrast Enhanced Mammography
Primary outcomes (1)
- measure
- To identify female MDACC patients with dense breasts who undergo contrast-enhanced mammography
- timeFrame
- through study completion; an average of 1 year.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patients 30-75 years of age with dense breasts (ACR BI-RADS categories C and D) who undergo routine yearly mammography at participating MDACC sites 2. Willingness to co-enroll or currently enrolled in PA17-0584 3. Willingness to participate in the study and ability to provide informed consent Exclusion Criteria: 1. Self-reported new breast symptoms since last mammogram including nipple discharge, palpable mass, skin dimpling, or focal pain. 2. Current or recent (within the prior 6 months) history of pregnancy or breast feeding 3. Personal history of breast cancer (DCIS or invasive breast cancer) 4. Treatment of any other type of cancer within the past 5 years excluding in-situ cervical and non-melanoma skin cancer 5. Breast biopsy within 6 months 6. Breast surgery within 12 months 7. Breast MRI, MBI, or CEM performed within 24 months 8. Known allergy to iodine-containing contrast agents 9. History of anaphylactic reaction to any substance that required hospitalization or IV placement in a patient with no known prior uneventful exposure to iodine-based IV contrast 10. Renal insufficiency (as defined by UTMDACC policy 3.30- attachment 1 (appendix D)
References
Publications (0)
Data not yet available
No reference posted for this study.