Clinical trial · Observational
Combined Elastography and Color Doppler Ultrasonography for Breast Screening With Ultrasound
Multicenter Prospective Study to Evaluate the Value of Combined Elastography and Color Doppler Ultrasonography for Breast Screening With Ultrasound
NCT01963624CI-TRIAL-00021861completedClinicalTrials.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 investigators hypothesis is that the combined use of elastography and color doppler ultrasonography can increase positive-predictive value of breast screening with ultrasound.
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 |
|---|---|---|---|
| Ultrasonography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Breast masses detected with screening US
- description
- Those assessed with conventional B-mode US alone and those assessed with combined elastography and color doppler ultrasonography along with B-mode US.
- interventionNames
- Device: Ultrasonography
Primary outcomes (1)
- measure
- Positive predictive value of breast screening with US
- timeFrame
- 1 year after enrollment
- description
- Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy.
Secondary outcomes (3)
- measure
- Sensitivity
- timeFrame
- 1 year after enrollment
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 30 years or older screened with breast ultrasound without specific symptoms * Women who underwent mammography within 3 months which showed no abnormality except for dense breast * Women who had at least one breast mass of BI-RADS category 3 or higher. Exclusion Criteria: * Women with breast implants * Women who are unwilling or unable to provide informed consent * Lesions larger than 3 cm * Lesions that are previously noted and followed-up in the same hospital
References
Publications (0)
Data not yet available
No reference posted for this study.