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NCT06547034 · ClinicalTrials.gov registry record
VisR for Noninvasively Interrogating Stromal Collagen Organization as a Breast Cancer Biomarker: Evaluation of Compression in Control Subjects
A clinical trial, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- 20
- Enrollment target
NCT06547034: Completed study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT06547034 is a clinical trial that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06547034 has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DEVICE Ultrasound
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-10-16 |
| Est. Completion | 2025-02-28 |
What the finished NCT06547034 record still lists
NCT06547034 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Ultrasound is the first listed.
NCT06547034 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06547034 about?
NCT06547034 is a clinical study titled "VisR for Noninvasively Interrogating Stromal Collagen Organization as a Breast Cancer Biomarker: Evaluation of Compression in Control Subjects". 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. Partic...
What is the current status of trial NCT06547034?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2024-10-16. Estimated completion is 2025-02-28.
What interventions are being tested in trial NCT06547034?
The interventions under investigation include: Ultrasound (DEVICE).
Who is sponsoring clinical trial NCT06547034?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
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