Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03785782 · ClinicalTrials.gov registry record
ARFI, VisR and DDAI Ultrasound for Improving Discrimination of Malignant and Unresponsive Breast Cancer
A clinical trial, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- 45
- Enrollment target
NCT03785782: Completed study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT03785782 is a clinical trial that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 45 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03785782 has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- 45 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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
Interventions
- DEVICE Ultrasound
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2018-05-10 |
| Est. Completion | 2021-07-15 |
What the finished NCT03785782 record still lists
NCT03785782 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 45 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Ultrasound is the first listed.
NCT03785782 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03785782 about?
NCT03785782 is a clinical study titled "ARFI, VisR and DDAI Ultrasound for Improving Discrimination of Malignant and Unresponsive Breast Cancer". 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 chemoth...
What is the current status of trial NCT03785782?
This trial is currently completed. The enrollment target is 45 participants. The study started on 2018-05-10. Estimated completion is 2021-07-15.
What interventions are being tested in trial NCT03785782?
The interventions under investigation include: Ultrasound (DEVICE).
Who is sponsoring clinical trial NCT03785782?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00804154 · 45 participants · Phase 1
Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer
- NCT01851694 · 45 participants · NA
Beta-cell Response to Incretin Hormones in Cystic Fibrosis
- NCT02896335 · 45 participants · Phase 2
Palbociclib and Pembrolizumab In Central Nervous System Metastases
- NCT03454035 · 45 participants · Phase 1
Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI