Academic-Industrial Partnership for Translation of Acoustic Angiography

NCT03544268 | Completed Phase 4 Results DMC FDA Device

• 2 other identifiers: LCCC17481R01CA189479-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Signs and Symptoms

Keywords

ultrasound; breast; angiography

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity

  To compare (using a reader study) the sensitivity and specificity of acoustic angiography to the sensitivity and specificity of conventional b-mode ultrasound in evaluation of breast lesions

  2 years

Secondary Outcomes (4)

• Area Under the Curve (AUC) of Acoustic Angiography

  2 years

• Radiologist Preference

  2 years

• Vessel Tortuosity (No Units)

  2 years

• Model-based Malignancy Score (Arbitrary Units)

  2 years

Study Arms (2)

Acoustic Angiography

EXPERIMENTAL

All clinical patients will be included in the experimental group.

Device: Acoustic Angiography; Drug: Definity

Image Optimization

EXPERIMENTAL

In addition to clinical patients, 30 participants will be recruited to aid in optimizing the imaging parameters.

Device: Acoustic Angiography; Drug: Definity

Interventions

Acoustic Angiography DEVICE

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. 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.

Acoustic Angiography; Image Optimization

Definity DRUG

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.

Acoustic Angiography; Image Optimization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 \<1% of newly diagnosed breast cancer)
• Institutionalized subject (prisoner or nursing home patient)
• Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease (COPD)
• Sonographically visible breast lesion larger than 2cm or greater than 3cm in depth from the skin surface
• Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®)
• Active cardiac disease including any of the following:
• Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association)
• Unstable angina.
• Severe arrhythmia (i.e. ventricular tachycardia, flutter fibrillation; ventricular premature complexes occurring close to the preceding T-wave, multifocal complexes).
• Myocardial infarction within 14 days prior to the date of proposed Definity® administration.
• Uncontrolled systemic hypertension (systolic blood pressure (BP) \>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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UNC Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Signs and Symptoms

Interventions

perflutren

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director, Clinical Research Operations, Department of Radiology
• Organization: University of North Carolina at Chapel Hill

rad_research@med.unc.edu

919-966-4997

Study Officials

• Yueh Lee, MD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental: Acoustic Angiography

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 1, 2018
• Study Start: March 25, 2019
• Primary Completion: May 25, 2021
• Study Completion: May 25, 2021
• Last Updated: April 1, 2022
• Results First Posted: April 1, 2022

Record last verified: 2022-03

Locations

US (1)