Clinical trial · Observational
Comparison of Diagnostic Performance of Digital Breast Tomosynthesis and Ultrasound in Women With Dense Breasts
NCT01910103CI-TRIAL-00017977completedClinicalTrials.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)
Diagnostic performance of digital breast tomosynthesis (DBT) would be not inferior to the that of breast ultrasound in women with dense breast.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Diagnostic performance (AUC: area of under ROC curve) of DBT and US
- timeFrame
- one year
- description
- The primary endpoint will be an analysis of the diagnostic performance of DBT to that of US for detecting breast cancer in the screening and diagnostic setting. The hypothesis is that DBT is not inferior to US for detecting breast cancer.
Secondary outcomes (1)
- measure
- Diagnostic sensitivity, sensitivity, negative predictive value, and positive predictive value of DBT and US for detecting breast cancer.
- timeFrame
- One year
- description
- We will calculate diagnostic sensitivity (%), sensitivity (%), negative predictive value (%), and positive predictive alue (%) of the DBT and US for the detection of breast cancer on a per-patient basis by using a BI-RADS score of 4 or 5 considered as test-positive and a BI-RADS score of 1, 2, or 3 considered as test-negative. Cases of women undergoing biopsy with malignant disease results were considered disease-positive. Cases of women with concordant benign biopsy results and women not undergoing biopsy with no evidence of breast malignancy after 1 year of clinical follow-up were considered diase-negative.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged at 20 years * Women who had heterogeneously dense or extremely dense parenchyma, either by prior mammography report or by review of prior mammograms * Signed study-specific informed consent prior to registration Exclusion Criteria: * Had breast surgery * Had breast core biopsy performed within the prior 6 months on the study
References
Publications (0)
Data not yet available
No reference posted for this study.