Clinical trial · Interventional
Earlier Breast Cancer Detection Using Automated Whole Breast Ultrasound With Mammography, Including Cost Comparisons
Earlier Breast Cancer Detection Using Automated Whole Breast Ultrasound With Screening Mammography, Including Cost Comparisons
NCT00649337CI-TRIAL-00001381unknownN/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 determine whether addition of automated whole breast ultrasound to the usual screening mammography in a population of asymptomatic women with mammographically dense breasts will result in a significantly greater number of breast cancers discovered than would be found by mammography alone.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Ultrasonography | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparison of Automated Whole Breast Ultrasound Screening with Blinded Screening Mammography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Adjunct screening with sonocine
- interventionNames
- Procedure: Comparison of Automated Whole Breast Ultrasound Screening with Blinded Screening Mammography
Primary outcomes (1)
- measure
- Numbers of breast cancers detected
- timeFrame
- One year after sonocine screening
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * be at least 35 years old, unless she has a strong pre-menstrual family history of breast cancer * have had no screening mammogram in the past 10 months * agree to have a screening mammogram that will not be reviewed until after a SonoCiné is performed * agree to have a screening mammogram in approximately one year * agree to answer follow up question in approximately one year * meet the usual criteria for breast screening (be asymptomatic of focal breast disease) * have no history of breast cancer for at least one year * agree to have both mammogram and SonoCiné if a physical finding or mammographic finding occurs within one year that requires biopsy Exclusion Criteria: * greater than 7 cm compressed breast thickness at mammography
References
Publications (1)
- DERIVEDKelly KM, Dean J, Comulada WS, Lee SJ. Breast cancer detection using automated whole breast ultrasound and mammography in radiographically dense breasts. Eur Radiol. 2010 Mar;20(3):734-42. doi: 10.1007/s00330-009-1588-y. Epub 2009 Sep 2. PMID 19727744