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

Primary Purpose

Signs and Symptoms

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Acoustic Angiography

About this trial

This is an interventional diagnostic trial for Signs and Symptoms focused on measuring Ultrasound, Breast, Angiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

UNC Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Acoustic Angiography

Healthy Volunteers

Arm Description

All breast patients will be included in the experimental group.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Area Under the Curve (AUC) of Acoustic Angiography

The AUC of acoustic angiography compared to the AUC of b-mode ultrasound

Radiologist Preference

To compare radiologist preference of acoustic angiography to conventional b-mode ultrasound for each lesion characteristic (shape, margins and vascularity)

Vessel Tortuosity (No Units)

To quantify vessel tortuosity metrics for the acoustic angiograph images, and to use these metrics to develop a model for predicting malignancy (a model-based malignancy score)

Model-based Malignancy Score (Arbitrary Units)

To compare the model-based malignancy score to the acoustic angiography reader study

Full Information

NCT ID

NCT02175628

First Posted

June 20, 2014

Last Updated

August 2, 2019

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02175628

Brief Title

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

Official Title

Comparison of the Sensitivity and Specificity of Acoustic Angiography (Micro-tumor Detection by Quantifying Tumor-induced Vascular Abnormalities) to the Sensitivity and Specificity of Conventional Ultrasound

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

June 2014 (undefined)

Primary Completion Date

June 30, 2018 (Actual)

Study Completion Date

June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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, comparison of radiologist preference for the two imaging techniques for each of 3 lesion characteristics, and quantification of vessel tortuosity based on acoustic angiography imaging results. These metrics will be used to develop a predictive model of malignancy which will subsequently be compared to results from radiology review.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Signs and Symptoms

Keywords

Ultrasound, Breast, Angiography

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acoustic Angiography

Arm Type

Experimental

Arm Description

All breast patients will be included in the experimental group.

Arm Title

Healthy Volunteers

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Acoustic Angiography

Intervention Description

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.

Primary Outcome Measure Information:

Title

Sensitivity and Specificity (Percentage)

Description

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

Time Frame

1.5 years

Secondary Outcome Measure Information:

Title

Area Under the Curve (AUC) of Acoustic Angiography

Description

The AUC of acoustic angiography compared to the AUC of b-mode ultrasound

Time Frame

1.5 years

Title

Radiologist Preference

Description

To compare radiologist preference of acoustic angiography to conventional b-mode ultrasound for each lesion characteristic (shape, margins and vascularity)

Time Frame

1.5 years

Title

Vessel Tortuosity (No Units)

Description

To quantify vessel tortuosity metrics for the acoustic angiograph images, and to use these metrics to develop a model for predicting malignancy (a model-based malignancy score)

Time Frame

1.5 years

Title

Model-based Malignancy Score (Arbitrary Units)

Description

To compare the model-based malignancy score to the acoustic angiography reader study

Time Frame

1.5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yueh Lee, MD, PhD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

UNC Hospital

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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