Clinical trial · Interventional
3D Ultrasound Breast Imaging
3D Multimodal Ultrasound Imaging for Breast Cancer
NCT04692818CI-TRIAL-00113145recruitingN/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 research is to study the efficacy of a new ultrasound imaging method for diagnosis of breast mass.
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 Tumor | Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GE Logiq E10 clinical ultrasound scanner | Diagnostic Test | — | UNRESOLVED |
| Verasonics research scanner | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Clinically indicated breast tumor biopsy
- description
- Subjects with breast lesion and are scheduled for clinically-indicated biopsy will have 3D Multimodal Ultrasound Imaging performed
- interventionNames
- Diagnostic Test: GE Logiq E10 clinical ultrasound scanner
- Diagnostic Test: Verasonics research scanner
Primary outcomes (1)
- measure
- BI-RADS Score
- timeFrame
- Baseline
- description
- BI-RADS scores will be obtained using 2D B-mode ultrasound images from the GE Logiq E10 clinical scanner, and using 3D B-mode images from the Verasonics scanner. A 7-point BI-RADS scale will be used, with a score of 1, 2, or 3 considered negative and 4a, 4b, 4c, and 5 considered positive.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult women ≥ 18 years of age. * solid breast lesion and ultrasound guided biopsy (either as part of their clinical care or through participation in other IRB-approved studies) * lesion size of 3mm or larger Exclusion Criteria: * \< 18 years of age. * Lacking capacity to consent * Pregnant or lactating * Receiving cancer therapy such as chemotherapy or radiation therapy
References
Publications (0)
Data not yet available
No reference posted for this study.