Clinical trial · Observational
ARFI, VisR and DDAI Ultrasound for Improving Discrimination of Malignant and Unresponsive Breast Cancer
- 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)
Purpose: The purpose of this study is to evaluate in vivo the diagnostic relevance of ultrasound-derived metrics for stiffness, elasticity, viscosity, and anisotropy. Participants: Forty women with breast lesions that have a BIRADS-4 or BIRADS-5 rating and forty women undergoing neoadjuvant chemotherapy (NAC) for malignant breast lesions will be recruited. Subjects will be recruited from the Breast Imaging Division of UNC Hospitals. Procedures (methods): In this exploratory clinical study, the investigators will attempt to demonstrate that ARFI, VisR, and DDAI ultrasound reliably detect malignant breast masses (Aim #1) and distinguish masses that respond to chemotherapy from those that do not (Aim #2). The ARFI, VisR, and DDAI imaging location will be on the surface of the breast, above the suspicious or malignant mass. This unblinded, open-label, exploratory study will be conducted in 40 women with diagnosed BIRADS-4 or -5 masses in Aim #1 and in 40 women with malignant masses undergoing neoadjuvant chemotherapy (NAC) in Aim #2.
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 |
|---|---|---|---|
| Ultrasound | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Women scheduled for biopsy
- description
- 40 participants with diagnosed BIRADS-4a, 4b, 4c, or -5 masses will be recruited. The investigators aim to have approximately 10 in each of the BIRADS categories (4a, 4b, 4c, 5), resulting in 40 total subjects for Aim #1.
- interventionNames
- Device: Ultrasound
- label
- Women scheduled for neoadjuvant chemo
- description
- 40 participants with malignant masses undergoing neoadjuvant chemotherapy (NAC) will be recruited.
- interventionNames
- Device: Ultrasound
Primary outcomes (16)
- measure
- Correlation of Peak Displacement (PD) for Detecting Malignancy
- timeFrame
- Baseline imaging
- description
- The correlation of each ultrasound metric will be analyzed by constructing separate receiver operating characteristic (ROC) curves. The ultrasound data were processed to calculate peak displacement (PD) and correlated with biopsy findings of malignant or benign. Peak Displacement (PD) - Maximum displacement of tissue in the breast lesion after an Acoustic Radiation Force Impulse (ARFI) excitation. Participants who have undergone breast ultrasonogram were categorized as BIRADS-4a, 4b, 4c, or -5 masses.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: \- Aim 1: Inclusion Criteria: * Patients are 30-90 years of age * Patients have breast masses with BIRADS 4a, 4b, 4c, or 5 rating * Lesion is sonographically visible with B-Mode ultrasound on diagnostic workup * Informed consent obtained and signed Aim 2: Inclusion Criteria: * Patients are 30-90 years * Patients who are or will be undergoing neoadjuvant chemotherapy (NAC) for stage 2 or 3 malignant breast lesions * Lesion is sonographically visible with B-Mode ultrasound on diagnostic workup * Informed consent is obtained and signed Exclusion Criteria: Subjects who meet any of the exclusion criteria will be excluded from study participation for both Aim 1 and Aim 2. * Inability to provide informed consent * Inability to communicate in English * Inability to remain motionless for 15 minutes * Suspicious or malignant breast mass deeper than 3 cm from skin surface * Previous biopsy or surgery to the site of the suspicious or malignant mass * Patients who are pregnant * Patients who are lactating * Patients with a history of masectomy * Patients with breast implants
References
Publications (0)
Data not yet available