Clinical trial · Observational
Digital Breast Tomosynthesis Versus Digital Mammography: A National Multicenter Trial
Digital Breast Tomosynthesis vs. Digital Mammography: A National Multicenter Trial
- 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)
The goal of this study is to determine the value of the new mammography technique called Digital Breast Tomosynthesis (DBT) compared to the current standard technique Digital Mammography for the early detection of Breast Cancer. DBT is able to compute a three-dimensional image of a breast from several low-dose mammographies taken from different angles while the device is moving around the breast in a circular motion. This should overcome a significant limitation of Digital Mammography arising from the masking of breast cancer in a mammography image caused by overlying normal breast tissue. This is a study conducted in several Austrian Breast Imaging Centers.
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
Design
Arms and outcomes
Arms (2)
- label
- Breast Cancer Screening Patients
- description
- Group 1 consists of Women referred to Breast Cancer Screening examinations at a participating Austrian Breast Imaging Site
- label
- Diagnostic Patients
- description
- Patients referred to a participating Breast Imaging Center for a clinically or radiologically detected breast lesion
Primary outcomes (1)
- measure
- Specificity of Digital Breast Tomosynthesis in the characterization of Breast lesions
- timeFrame
- One year
Secondary outcomes (1)
- measure
- Sensitivity of Digital Breast Tomosynthesis in the detection of malignant breast lesions
- timeFrame
- One year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 25 years (40 years or older for Screening Cohort) * No history of breast cancer * Written informed consent * Asymptomatic women in follow up for early detection of breast cancer or * Patients with a recent positive mammography (BI-RADS 3-5) Exclusion Criteria: * Pregnant and breast feeding women * Unable to tolerate breast compression * Breast implants * Unable to understand or execute written informed consent
References
Publications (0)
Data not yet available