Clinical trial · Observational
VisR for Noninvasively Interrogating Stromal Collagen Organization as a Breast Cancer Biomarker: Evaluation of Compression in Control Subjects
VisR Ultrasound for Noninvasively Interrogating Stromal Collagen Organization in Women as a Breast Cancer Biomarker: Evaluation of Surface Compression in Control Subjects
- 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 elasticity, viscosity, and anisotropy. To this end, we will investigate the effect of applied compression during imaging on elasticity, viscosity, and anisotropy measurements. Participants: Twenty women with negative mammograms and no history of breast disease will be recruited. The subjects will be split into two cohorts of ten each, the first cohort aged 30-45 and the second cohort aged 46-90. 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 measurements of elasticity, viscosity, and anisotropy in healthy breast tissue vary based on applied pre-compression. This unblinded, open-label study will be conducted in 20 women with negative mammogram results and no history of breast disease.
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
- Ages 30-45
- description
- Women ages 30-45 who have received a mammogram in the past year with negative results and have no history of breast disease.
- interventionNames
- Device: Ultrasound
- label
- Ages 46-90
- description
- Women ages 46-90 who have received a mammogram in the past year with negative results and have no history of breast disease.
- interventionNames
- Device: Ultrasound
Primary outcomes (19)
- measure
- ARFI PD at 0% Strain
- timeFrame
- Baseline imaging
- description
- Average ARFI Peak Displacement (PD) value across imaging angles with 0% strain applied. Peak Displacement (PD) - Maximum displacement of tissue in the breast after an Acoustic Radiation Force Impulse (ARFI) excitation.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Patients are 30-90 years of age * Patients have received a negative result from mammogram screening in past year * Patients have no history of breast disease * Informed consent obtained and signed Exclusion Criteria: * Inability to provide informed consent * Inability to communicate in English * Inability to remain motionless for 15 minutes * Any pathologies of the breast or history of breast disease * Patients who are pregnant * Patients who are lactating * Patients with breast implants * Patients with implanted cardioverters or pacemakers
References
Publications (0)
Data not yet available