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Comparison of the Sensitivity and Specificity of Acoustic Angiography to the Sensitivity and Specificity of Conventional Ultrasound
NCT02175628 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DEVICE Acoustic Angiography
Study Locations (1)
North Carolina
- UNC Hospital — Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2014-06 |
| Est. Completion | 2018-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02175628
The ClinicalTrials.gov registry entry for NCT02175628 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 374 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Signs and Symptoms appearing as the primary indexed condition, and to 1 intervention — of which Acoustic Angiography is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02175628 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02175628 about?
NCT02175628 is a clinical study titled "Comparison of the Sensitivity and Specificity of Acoustic Angiography to the Sensitivity and Specificity of Conventional Ultrasound". 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 ...
What is the current status of trial NCT02175628?
This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2014-06. Estimated completion is 2018-06-30.
What conditions does trial NCT02175628 study?
This clinical trial studies the following conditions: Signs and Symptoms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02175628?
The interventions under investigation include: Acoustic Angiography (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02175628?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 374 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02175628 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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