Clinical trial · Interventional
A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses
A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses: A Pilot Study
NCT00826488CI-TRIAL-00018108completedEarly Phase 1ClinicalTrials.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 compare conventional breast imaging and diagnostic work-up (2 dimensional imaging) to digital breast tomosynthesis (3 dimensional imaging) in the appearance of non-calcified breast masses. It is thought that non-calcified breast masses will be better visualized with the new 3D technology.
Conditions
Conditions (2)
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 |
| Fibrocystic Disease of Breast | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digital Breast Tomosynthesis | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- observational
- description
- Observational
- interventionNames
- Device: Digital Breast Tomosynthesis
Primary outcomes (1)
- measure
- It is anticipated that out of 100 subjects recalled for additional breast imaging that 10 women will be recalled for biopsy. By adding 2D & 3D imaging, it is anticipated that 30 subjects out of 100 will have needed no workup.
- timeFrame
- 9 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Any race or ethnicity * At least 35 years old * Prior screening or full diagnostic mammogram at Barnes Jewish Breast Health Center Exclusion Criteria: * Unable or unwilling to undergo informed consent * Subjects who have breast implants * Subjects who are unable or unwilling to tolerate compression * Subjects who are pregnant or who think they may be pregnant * Subjects who are currently lactating * Men * Women less than 35 years old * Women greater than 80 years old * Subjects whose breasts are larger than the tomosynthesis detector
References
Publications (0)
Data not yet available
No reference posted for this study.