Clinical trial · Interventional
Multi-parametric Breast Ultrasound Imaging as a Potential Biomarker for Breast Cancer
NCT04480437CI-TRIAL-00055676mp-BUScompletedN/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)
It is studied whether multi-parametric biomarkers such as speed-of-sound imaging or others, applied during breast ultrasound (BUS) imaging allows to classify lesions according to its malignancy. The standard reference intervention is BUS guided biopsy or the consensus of the board of experts judging the BUS imaging results if no biopsy is done.
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 |
|---|---|---|---|
| mp-BUS data collection | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study Intervention
- description
- mp-BUS data collection
- interventionNames
- Device: mp-BUS data collection
Primary outcomes (1)
- measure
- Speed-of-sound imaging shows malignancy of lesion
- timeFrame
- 6 months
- description
- Evaluate the non-inferiority or superiority of the multi-parametric method compared to the standard ultrasound technique, using BUS guided biopsy as gold standard, to determine the malignancy of a lesion in woman breast.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women who are suspected or suspected of having breast cancer and who are advised to perform a detailed breast ultrasound or tissue sampling (biopsy) * Classification into groups: * Group 1: Foreseen for BUS guided biopsy * Group 2: BI-RADS classification I, II and III and foreseen for BUS only based diagnosis Exclusion Criteria: * Lactating women * Women with mastitis * Vulnerable persons
References
Publications (0)
Data not yet available
No reference posted for this study.