Comparison of the Sensitivity and Specificity of Acoustic Angiography to the Sensitivity and Specificity of Conventional Ultrasound

NCT02175628 | Completed Results DMC

• 2 other identifiers: LCCC1405R01CA170665
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: This study will evaluate a new ultrasound imaging technology called acoustic angiography. Acoustic angiography uses an ultrasound contrast agent, already FDA approved for use in cardiology, to enhance imaging of blood vessels. Since acoustic angiography uses ultrasound, and not x-rays, the patient is not exposed to ionizing radiation, unlike traditional angiography and mammography. Specific goals will be to evaluate the quality of the images provided by acoustic angiography in the human breast, and furthermore to evaluate whether or not acoustic angiography provides additional diagnostic information over traditional ultrasound which could provide an improvement in assessing breast lesions. Specifically, this additional diagnostic information will hopefully enable us to reduce false positive tests and discriminate lethal cancers from non-lethal disease. Participants: The investigators are recruiting 60 patients from the UNC Breast Clinic who are undergoing core needle biopsy or surgical biopsy (BIRADS 4 and 5 breast lesions). Procedures (methods): Acoustic Angiography imaging will be performed in conjunction with standard diagnostic imaging, including b-mode ultrasound . Then, a reader study will be conducted to compare these modalities. Finally, the images will be analyzed with image processing techniques to determine quantitative metrics exhibited by the blood vessel morphology in the images. These metrics will be utilized to develop a "malignancy score" equation to predict malignancy of a lesion.

Conditions

Signs and Symptoms

Keywords

Ultrasound; Breast; Angiography

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity (Percentage)

  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

  1.5 years

Secondary Outcomes (4)

• Area Under the Curve (AUC) of Acoustic Angiography

  1.5 years

• Radiologist Preference

  1.5 years

• Vessel Tortuosity (No Units)

  1.5 years

• Model-based Malignancy Score (Arbitrary Units)

  1.5 years

Study Arms (2)

Acoustic Angiography

EXPERIMENTAL

All breast patients will be included in the experimental group.

Device: Acoustic Angiography

Healthy Volunteers

EXPERIMENTAL

A volunteer group was added to the study to perfect the image acquisition techniques.

Device: Acoustic Angiography

Interventions

Acoustic Angiography DEVICE

Acoustic angiography imaging involves a research high frequency ultrasound scanner (VisualSonics Vevo 770) 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. All image data will be de-identified and transferred for off-line analysis based on a study ID. The research images will NOT be interpreted or analyzed for clinical decisions related to the patient.

Acoustic Angiography; Healthy Volunteers

Eligibility Criteria

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

You may qualify if:

• Women ≥18 years old
• Scheduled for breast core needle or surgical biopsy of at least one breast lesion based on suspicious breast lesion (BIRADS score of 4 or 5) from pre-study SOC imaging studies
• Center of suspicious lesion is not deeper than 1.5 cm, and the diameter of the lesion is not greater than 2 cm
• 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)
• Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®)
• Right to left shunt, severe pulmonary hypertension (pulmonary artery pressure \>90mmHg), or adult respiratory distress syndrome
• 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

Sponsors & Collaborators

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

Study Sites (1)

UNC Hospital

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Signs and Symptoms

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Results Point of Contact

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

rad_research@med.unc.edu

9199664997

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: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 26, 2014
• Study Start: June 1, 2014
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: August 5, 2019
• Results First Posted: August 5, 2019

Record last verified: 2018-10

Locations

US (1)