Clinical trial · Interventional
3D Ultrasound Microvessel Imaging for Breast Masses
NCT04925817CI-TRIAL-00077819completedEarly 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)
This early phase I trial studies how well 3D ultrasound microvessel imaging works for the diagnosis of breast mass. The 3D ultrasound microvessel imaging technology demonstrates significantly increased vessel detection sensitivity over conventional doppler methods without the need of using contrast agents. This study may improve cancer diagnosis and reduce unnecessary biopsy on benign tumors.
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 Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Ultrasound Microvessel Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (ultrasound microvessel imaging)
- description
- Patients undergo 3 D ultrasound microvessel imaging over 45 minutes. Patients' medical records are reviewed.
- interventionNames
- Other: Electronic Health Record Review
- Procedure: Ultrasound Microvessel Imaging
Primary outcomes (8)
- measure
- Ultrasound diagnostic accuracy using McNemar's test
- timeFrame
- Up to 1 year
- description
- Will be compared between conventional ultrasound (US) and conventional US + 3 dimensional (D) ultrasound microvessel imaging (UMI) using McNemar's test.
- measure
- Ultrasound parameters sensitivity using McNemar's test
- timeFrame
- Up to 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women with solid breast lesion who are scheduled for a clinically indicated ultrasound-guided biopsy. * Lesion size of 3 mm or larger. * Age 18 or greater. Exclusion Criteria: * Women with previous breast surgery or breast implant. * Lacking the capacity to consent. * Women who are pregnant or lactating. * Women who are receiving cancer therapy such as chemotherapy or radiation therapy.
References
Publications (0)
Data not yet available
No reference posted for this study.