Clinical trial · Interventional
Study of Dual-energy (DE) Contrast-enhanced (CE) Digital Mammography
Pilot Study of Dual-energy (DE) Contrast-enhanced (CE) Digital Mammography to Detect Breast Cancer in Patients With Increased Breast Density (Breast Imaging-Reporting And Data System (BI-RADS) Category c or d)
- 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 is a feasibility study to evaluate dual-energy (DE) contrast-enhanced (CE) digital mammography to detect breast cancer in patients with increased breast density (BI-RADS category c or d). Eligible patients will be invited to have full-field digital mammography and dual-energy (DE) contrast-enhanced (CE) digital mammography to compare accuracy of the imaging methods for the detection of breast cancer.
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 |
|---|---|---|---|
| digital mammography | Device | — | UNRESOLVED |
| Dual-Energy Contrast-Enhanced (DECE) mammography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Contrast enhanced mammography vs standard digital mammogram
- description
- Contrast-enhanced spectral mammography for the detection breast cancer .
- interventionNames
- Device: Dual-Energy Contrast-Enhanced (DECE) mammography
- Device: digital mammography
Primary outcomes (2)
- measure
- Percent Accuracy of Contrast Mammography
- timeFrame
- 1 year
- description
- •The primary endpoint of this study is to determine the accuracy of DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (Breast Imaging-Reporting And Data System (BI-RADS) category c or d breast density).
- measure
- Number of Participants With Cancer Detected
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed informed consent 2. At least 19 years old 3. Glomerular filtration rate\> 60 4. Heterogeneously or extremely dense breasts (BI-RADS category c or d). Exclusion Criteria: 1. History of iodinated contrast allergy 2. Pregnant or lactating as determined by routine standard practice 3. Personal history of breast cancer 4. History of prior breast excisional biopsy (Patients with a history of core needle biopsy will not be excluded) 5. History of prior breast reduction mammoplasty surgery 6. History of prior breast augmentation surgery 7. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
References
Publications (0)
Data not yet available