Clinical trial · Interventional
Efficacy of Digital Breast Tomosynthesis + Standard 2- Dimensional Mammography in Breast Cancer
Efficacy of Digital Breast Tomosynthesis (DBT) in Addition to Standard 2- Dimensional Mammography in Evaluating Extent of Disease in Newly Diagnosed Breast Cancer Patients
NCT03190083CI-TRIAL-00059314completedN/AResults postedClinicalTrials.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)
The purpose of this study is to determine if a 3-dimensional mammogram (DBT) may provide additional information to evaluate the extent of disease and additional findings that would aid in staging a new breast cancer patient. This would impact surgical planning and improve patient outcomes.
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 |
|---|---|---|---|
| 2-dimensional mammogram | Device | — | UNRESOLVED |
| digital breast tomosynthesis (DBT) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 3-dimensional tomosynthesis mammogram
- description
- The patients assigned a Breast imaging-reporting and data system (BIRADS) 5 category at the time of diagnosis and all new diagnosed breast cancer patients, will undergo a separate 2-D plus DBT in addition to the standard 2-D mammogram
- interventionNames
- Device: 2-dimensional mammogram
- Device: digital breast tomosynthesis (DBT)
Primary outcomes (1)
- measure
- Number of Participants for Which DBT Altered Surgical Plan
- timeFrame
- At completion of 3-Dimensional mammogram (1 day)
- description
- Only positive findings, like an additional site of cancer or atypical pathology like Atypical ductal/ lobular hyperplasia, papilloma, DCIS/LCIS (findings requiring surgical intervention), will be taken into account when estimating the frequency of changes to surgical management
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * New diagnosis of breast cancer * New diagnosis if a previous breast cancer patient with negative surgical margins * Patients willing to sign a written informed consent form Exclusion Criteria: * High risk benign lesions as the primary pathology diagnosis
References
Publications (0)
Data not yet available
No reference posted for this study.