This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02175628
First received: June 20, 2014
Last updated: April 24, 2017
Last verified: April 2017
  Purpose

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.


Condition Intervention
Signs and Symptoms Device: Acoustic Angiography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Sensitivity and specificity (Percentage) [ Time Frame: 1.5 years ]
    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 [ Time Frame: 1.5 years ]
    The AUC of acoustic angiography compared to the AUC of b-mode ultrasound

  • Radiologist preference [ Time Frame: 1.5 years ]
    To compare radiologist preference of acoustic angiography to conventional b-mode ultrasound for each lesion characteristic (shape, margins and vascularity)

  • Vessel tortuosity (No units) [ Time Frame: 1.5 years ]
    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) [ Time Frame: 1.5 years ]
    To compare the model-based malignancy score to the acoustic angiography reader study


Estimated Enrollment: 60
Study Start Date: June 2014
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acoustic Angiography
All patients will be included in the experimental group.
Device: Acoustic Angiography

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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02175628

Contacts
Contact: Shanah R Kirk 919-966-6957 shanah_kirk@med.unc.edu
Contact: Doreen Steed 919-966-9284 doreen_steed@med.unc.edu

Locations
United States, North Carolina
UNC Hospital Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Michele Vickers    919-843-3670    michele_vickers@med.unc.edu   
Contact: Shanah R Kirk    919-966-6957    shanah_kirk@med.unc.edu   
Sub-Investigator: Paul Dayton, PhD         
Principal Investigator: Yueh Lee, MD, PhD         
Sub-Investigator: Cherie Kuzmiak, DO         
Sub-Investigator: Donglin Zeng, PhD         
Sub-Investigator: Sheila Lee, MD         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Yueh Lee, MD, PhD University of North Carolina, Chapel Hill
  More Information

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02175628     History of Changes
Other Study ID Numbers: LCCC1405
R01CA170665 ( US NIH Grant/Contract Award Number )
Study First Received: June 20, 2014
Last Updated: April 24, 2017

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Ultrasound
Breast
Angiography

Additional relevant MeSH terms:
Hypersensitivity
Signs and Symptoms
Immune System Diseases

ClinicalTrials.gov processed this record on June 27, 2017