Phase 4 N=20 Diagnostic

Academic-Industrial Partnership for Translation of Acoustic Angiography

Signs and Symptoms

Bottom Line

View on ClinicalTrials.gov: NCT03544268 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2022

Primary outcome: Primary: Sensitivity and Specificity

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Acoustic Angiography (Device); Definity (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: UNC Lineberger Comprehensive Cancer Center
Primary completion: May 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Sensitivity and Specificity	—	—
SECONDARY Area Under the Curve (AUC) of Acoustic Angiography	—	—
SECONDARY Radiologist Preference	—	—
SECONDARY Vessel Tortuosity (No Units)	—	—
SECONDARY Model-based Malignancy Score (Arbitrary Units)	—	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Subject must meet all of the inclusion criteria to participate in this study:

Women ≥18 years old
Patient had a diagnostic breast ultrasound study performed at UNC
Scheduled for a core needle or surgical breast biopsy of at least one breast lesion that is 2 cm or less in size and 3 cm in depth from the skin surface
Lesion visualized on ultrasound
Able to provide informed consent
Negative urine pregnancy test in women of child-bearing potential

Exclusion Criteria All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation

Male (it is uncommon for men to present for imaging and the overwhelming majority of findings are non-cancerous and do not lead to biopsy; male breast cancer represents 150 mm Hg and/or diastolic BP >90 mm Hg despite optimal medical management).
Any woman who is pregnant or has reason to believe she is pregnant or any woman who is lactating (the possibility of pregnancy has to be excluded by negative urine β-HCG results, obtained within 24 hours before the perflutren lipid administration, or on the basis of patient history as defined by the UNC IRB SOP 4801 for child bearing potential)

Healthy Volunteers for Image Optimization

In addition to these clinical patients, 15 participants will be recruited to aid in optimizing the imaging parameters. These subjects must be willing to participate and able to provide written informed consent. However, these participants do not need to present any of the clinical indications as given for patients.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03544268). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.