Clinical trial NCT03544268: Academic-Industrial Partnership for Translation of Acoustic Angiography
Official title: Academic-Industrial Partnership for Translation of Acoustic Angiography
Conditions: Signs and Symptoms
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.
Interventions:
description: Acoustic angiography imaging involves a research high frequency ultrasound scanner and a prototype transducer as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to the acoustic angiography for localization. The imaging also requires administration of Definity ultrasound contrast agent.<br/>Acoustic angiography imaging will be performed by trained medical personnel using mild compression to eliminate motion. Total imaging time is estimated to be less than 15 minutes.
name: Acoustic Angiography
type: Device
description: Baseline B-mode US will be performed to confirm the lesions being imaged (unless it is a subject with no lesions, then a basic B-mode US will be performed). Perflutren is a diagnostic drug that is intended to be used for contrast enhancement. The vial contains a clear, colorless, sterile, non-pyrogenic, hypertonic solution which is activated by mechanical agitation with Vialmix®.It will be dispensed in inactivated form to a study team member. The contrast agent will be activated just prior to administration (ideally to be used within 5 minutes of activation). Contrast agent Definity will be activated according to package insert instructions, including use of VialMix®, the device used to activate Definity. Administration will occur IV in coordination with staff trained specifically in contrast ultrasound imaging.The total imaging time is anticipated to be less than 30 minutes.
name: Definity
type: Drug
Study arms:
design_group_description: All clinical patients will be included in the experimental group.
design_group_title: Acoustic Angiography
design_group_type: Experimental
design_group_description: In addition to clinical patients, 30 participants will be recruited to aid in optimizing the imaging parameters.
design_group_title: Image Optimization
design_group_type: Experimental
Sponsor: Lineberger Comprehensive Cancer Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 全氟丙烷脂质微球
lang: CN
name: Perflutren lipid microsphere
lang: EN