Clinical trial · Interventional
Detection and/or Evaluation of Dense Breast Abnormalities Using Tomosynthesis and Digital Mammography
Assessment of Emerging Technology: Comparison of Breast Tomosynthesis and Digital Mammography in the Evaluation of Heterogeneously Dense and Extremely Dense Breasts
NCT00722059CI-TRIAL-00013644completedEarly 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 3D mammography with digital mammography in women with dense breasts for the detection and evaluation of masses and/or breast cancer.
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 Abnormalities | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Tomosynthesis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Subjects will undergo a 3D breast Tomosynthesis imaging scan. This is a one time breast imaging scan will last approximately 15 minutes.
- interventionNames
- Procedure: Breast Tomosynthesis
Primary outcomes (1)
- measure
- Measure of digital tomosynthesis and digital mammography test performance.
- timeFrame
- 3 weeks
- description
- Interest of sensitivity, specificity and area under region of concern curve for malignant mass detection. During review, the number of masses and location and size of each mass will be recorded. An additional estimate of probability of malignancy will be recorded for each image sets.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Females 30 years of age or older. * Dense Breasts. * Has undergone clinical two view mammogram and diagnostic breast imaging evaluation. * Suspicious or palpable mass and scheduled for biopsy. Exclusion Criteria: * Pregnant or lactating women. * Prior personal history of breast cancer. * Prior breast augmentation with implants or silicon injection. male patients. * No two view mammogram as part of breast imaging evaluation. * Breast density of almost entirely fatty/scattered fibroglandular densities.
References
Publications (0)
Data not yet available
No reference posted for this study.