An interventional study of Acoustic Angiography in Signs and Symptoms, sponsored by UNC Lineberger Comprehensive Cancer Center. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-05.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Not applicable, Interventional, and Diagnostic
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.
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.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's enrollment of 23 is below the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.
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Exclusion Criteria:
Active cardiac disease including any of the following:
All breast patients will be included in the experimental group.
Device: Acoustic Angiography
A volunteer group was added to the study to perfect the image acquisition techniques.
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.
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
Time frame: 1.5 years
Area Under the Curve (AUC) of Acoustic Angiography
The AUC of acoustic angiography compared to the AUC of b-mode ultrasound
Time frame: 1.5 years
Radiologist Preference
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
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)
Time frame: 1.5 years
Model-based Malignancy Score (Arbitrary Units)
To compare the model-based malignancy score to the acoustic angiography reader study
Time frame: 1.5 years
| Milestone | Acoustic Angiography | Healthy Volunteers |
|---|---|---|
| Started | 6 | 17 |
| Completed | 6 | 17 |
| Not completed | 0 | 0 |
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
No measurements were reported for this outcome.
The AUC of acoustic angiography compared to the AUC of b-mode ultrasound
No measurements were reported for this outcome.
To compare radiologist preference of acoustic angiography to conventional b-mode ultrasound for each lesion characteristic (shape, margins and vascularity)
No measurements were reported for this outcome.
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)
No measurements were reported for this outcome.
To compare the model-based malignancy score to the acoustic angiography reader study
No measurements were reported for this outcome.
Collected over 30 minutes post imaging. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acoustic Angiography | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Healthy Volunteers | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Age, Categorical(Participants) | Acoustic Angiography | Healthy Volunteers | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 15 | 20 |
| >=65 years | 1 | 2 | 3 |
| Age, Continuous(years) | Acoustic Angiography | Healthy Volunteers | Total |
|---|---|---|---|
| Mean | 48 ± 14 | 43 ± 17 | 45 ± 17 |
| Sex: Female, Male(Participants) | Acoustic Angiography | Healthy Volunteers | Total |
|---|---|---|---|
| Female | 6 | 14 | 20 |
| Male | 0 | 3 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Acoustic Angiography | Healthy Volunteers | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 6 | 8 | 14 |
| Unknown or Not Reported | 0 | 8 | 8 |
| Race (NIH/OMB)(Participants) | Acoustic Angiography | Healthy Volunteers | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 4 |
| White | 4 | 5 | 9 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 10 | 10 |
| Region of Enrollment(participants) | Acoustic Angiography | Healthy Volunteers | Total |
|---|---|---|---|
| United States | 6 | 17 | 23 |
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