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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 is a clinical trial that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 45 participants.
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.
Interventions
- DEVICE Ultrasound
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2018-05-10 |
| Est. Completion | 2021-07-15 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03785782
The ClinicalTrials.gov registry entry for NCT03785782 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ultrasound is the first listed.
NCT03785782 reports 0 study locations.
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.
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