Clinical trial NCT03544268: Academic-Industrial Partnership for Translation of Acoustic Angiography
Official title: Academic-Industrial Partnership for Translation of Acoustic Angiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Signs and Symptoms
Keywords: ultrasound
breast
angiography
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-06-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Experimental: Acoustic Angiography
Primary purpose: DIAGNOSTIC

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.

Detailed description: Increasing the sensitivity and specificity of diagnostic imaging in patients at high risk for breast cancer could provide substantial clinical benefit by improving diagnosis, preventing over-treatment, and reducing healthcare costs. Acoustic angiography is a new type of contrast enhanced ultrasound imaging which is specifically sensitive to microvascular structure and density. It evaluates tumor micro-vasculature and may provide a powerful prognostic tool for the diagnosis of breast cancer, and eventually for treatment evaluation.

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. 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.

Eligibility criteria: Inclusion Criteria

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

1. Women ≥18 years old
2. Patient had a diagnostic breast ultrasound study performed at UNC
3. 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
4. Lesion visualized on ultrasound
5. Able to provide informed consent
6. 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

1. 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)
2. Institutionalized subject (prisoner or nursing home patient)
3. Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease (COPD)
4. Sonographically visible breast lesion larger than 2cm or greater than 3cm in depth from the skin surface
5. Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®)
6. 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).
7. 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.

Primary outcomes:
measure: Sensitivity and Specificity
timeFrame: 2 years
Secondary outcomes:
measure: Area Under the Curve (AUC) of Acoustic Angiography
timeFrame: 2 years
measure: Radiologist Preference
timeFrame: 2 years
measure: Vessel Tortuosity (No Units)
timeFrame: 2 years
measure: Model-based Malignancy Score (Arbitrary Units)
timeFrame: 2 years
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Hospitals
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Yueh Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: