NCT03544268 is a Phase 4 clinical trial of Acoustic Angiography in Signs and Symptoms, sponsored by UNC Lineberger Comprehensive Cancer Center.

Who is sponsoring NCT03544268?

NCT03544268 is sponsored by UNC Lineberger Comprehensive Cancer Center.

What drugs are being tested in NCT03544268?

Interventions in NCT03544268: Acoustic Angiography, Definity.

What condition does NCT03544268 study?

NCT03544268 studies Signs and Symptoms.

Is NCT03544268 still recruiting?

NCT03544268 is currently completed. Last updated 1 April 2022.

Are results published for NCT03544268?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-04-01 · How we verify

NCT03544268

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Academic-Industrial Partnership for Translation of Acoustic Angiography

Completed Phase 4 Results posted Last updated 1 April 2022

What this trial tests

Phase 4 trial testing Acoustic Angiography in Signs and Symptoms in 20 participants. Completed in 25 May 2021.

Timeline

25 March 2019

Primary endpoint
25 May 2021

25 May 2021

Quick facts

Lead sponsor	UNC Lineberger Comprehensive Cancer Center
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	diagnostic
Enrollment	20
Start date	25 March 2019
Primary completion	25 May 2021
Estimated completion	25 May 2021
Sites	1 location across United States

Drugs / interventions tested

Acoustic Angiography
Definity — full drug profile →

Conditions studied

Signs and Symptoms — all drugs for Signs and Symptoms →

Sponsor

UNC Lineberger Comprehensive Cancer Center — full company profile →

Who can join

18 and older, any sex, with Signs and Symptoms. Patients with the condition only — healthy volunteers not accepted.

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 minutes post imaging. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Acoustic Angiography

Serious: 0/3 (0%)

Deaths: 0/3

Image Optimization

Serious: 0/15 (0%)

Deaths: 0/15

Other adverse events (1 terms — click to expand)

Reaction	System	Acoustic Angiography	Image Optimization
Flushing	Blood and lymphatic system disorders	—	—

Data from ClinicalTrials.gov NCT03544268 adverse events section.

Sponsor's own description

Purpose: The primary objective of this single arm study is to compare the sensitivity and specificity of acoustic angiography with traditional b-mode ultrasound in the distinction of malignant versus benign breast lesions. Secondary objectives include a comparison of area under the curve (AUC) for acoustic angiography versus b-mode ultrasound, and comparison of radiologist preference for the two imaging techniques for each of 3 lesion characteristics. Participants: Sixty patients who are to have a clinical surgical breast biopsy based on results from pre-study standard of care (SOC) imaging will be recruited from the UNC Breast Clinic for participation in the study. Procedures (methods): This is a one arm single center study of patients with suspicious breast lesions (BIRADS 4 or 5) from the UNC Breast Clinic that consent to undergo an acoustic angiography in conjunction with b-mode ultrasound prior to their scheduled biopsy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Acoustic Angiography

Trials testing the same drug.

NCT04136912 — 3-D Super Resolution Ultrasound Microvascular Imaging · Phase 2 · terminated

Other UNC Lineberger Comprehensive Cancer Center trials

Trials by the same sponsor.

NCT06656936 — The PharmFIT Study · NA · not yet recruiting
NCT05937659 — Incorporating Biometric Data for Patients Receiving Concurrent Chemotherapy & RT · not yet recruiting
NCT07479199 — Local Radiofrequency Ablation Plus External Beam Radiation for the Treatment of Painful Thoracic and Lumbar Spine Tumors · not yet recruiting
NCT07069595 — PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease · Phase 2 · recruiting
NCT04266730 — Trial of a Personalized and Adaptive Neoantigen Dose-Adjusted Vaccine Concurrently With Pembrolizumab · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03544268 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center
Last refreshed: 1 April 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03544268.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing