N/A
Completed N=128
Study of Dual-energy (DE) Contrast-enhanced (CE) Digital Mammography
Source: ClinicalTrials.gov NCT02995980 ↗Enrolled (actual)
128
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Percent Accuracy of Contrast Mammography — 100; 67 percentage of accuracy
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Accuracy of Contrast Mammography |
100; 67 | — |
| PRIMARY Number of Participants With Cancer Detected |
3; 2 | — |
| SECONDARY Number of Call Backs With Contrast Mammography |
10; 11 | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent
- At least 19 years old
- Glomerular filtration rate> 60
- Heterogeneously or extremely dense breasts (BI-RADS category c or d).
Exclusion Criteria
- History of iodinated contrast allergy
- Pregnant or lactating as determined by routine standard practice
- Personal history of breast cancer
- History of prior breast excisional biopsy (Patients with a history of core needle biopsy will not be excluded)
- History of prior breast reduction mammoplasty surgery
- History of prior breast augmentation surgery
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
Data sourced from ClinicalTrials.gov (NCT02995980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.