Clinical trial · Interventional
A Comparison of the 15 and 30 Acquisition Angle Breast Tomosynthesis Mammography for Breast Abnormalities
A Comparison of 15 and 30 Acquisition Angle Breast Tomosynthesis Mammography in the Visualization and Characterization of Breast Abnormalities
NCT00990483CI-TRIAL-00074551completedN/AClinicalTrials.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 conduct an initial investigation into whether an alternative method of using 3D imaging might offer accurate diagnostic performance at a reduced patient radiation exposure in comparison to conventional 2D screening and diagnostic mammography and conventional 2D + 3D imaging methods.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D mammograpgy system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 3D investigational imaging
- description
- patients returning with an area of interest will undergo investigational 3D imaging in 2 modes of imaging to the breast of interest and compare to the subjects standard of care imaging
- interventionNames
- Device: 3D mammograpgy system
Primary outcomes (1)
- measure
- If the new imaging modes are successful, they will represent a method of reducing patient exposure for future imaging because they are designed to be used in 3D imaging only.
- timeFrame
- Fall 2010
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Subject is female of any race and ethnicity * Subject is at least 40 years old * The screening and diagnostic mammograms were performed at the recruiting institution on a Hologic Selenia System * Subject is categorized as BI-RADS 0 because if mass, density, or calcifications detected on the basis of screening or diagnostic mammography * Subject will undergo study imaging within 30 days of standard of care imaging Exclusion Criteria: * Patients who are pregnant or think they may be pregnant * Patients who are breast feeding * Subjects unable or unwilling to undergo informed consent * Subjects with breast implants
References
Publications (0)
Data not yet available
No reference posted for this study.