Clinical trial · Interventional
Screening CEDM in Intermediate and High-Risk Patient Populations
Screening Contrast Enhanced Mammography (CEDM) in Intermediate and High-Risk Patient Populations
NCT03859492CI-TRIAL-00069073completedN/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)
This research study is being done to determine if Contrast Enhanced Digital Mammography (CEDM) can improve breast cancer detection and can be used as an additional screening method to the standard mammographic screening.
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 Digital Mammography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intermediate or high-risk breast cancer subjects
- description
- Subjects with a negative mammogram who are intermediate or high-risk for breast cancer will get supplemental screening with contrast enhanced digital mammography (CEDM)
- interventionNames
- Device: Contrast Enhanced Digital Mammography
Primary outcomes (1)
- measure
- Breast Cancer
- timeFrame
- 3 years
- description
- Number of subjects diagnosed with breast cancer
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 35 and had a negative routine mammogram within 6 months. * Qualifies as intermediate or high-risk (\>15% lifetime risk of breast cancer as defined by IBIS version 8). Exclusion Criteria: * Known breast cancer * Previously had negative MBI or MRI within 12 months of study * Pregnant or lactating * Contraindication to intravenous iodinated contrast * Unable to understand or sign informed consent * Self-reported signs or symptoms of breast cancer
References
Publications (0)
Data not yet available
No reference posted for this study.