3-D Super Resolution Ultrasound Microvascular Imaging
- Conditions
- Breast CancerThyroid Cancer
- Interventions
- Device: Acoustic Angiography
- Registration Number
- NCT04136912
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Brief Summary
This is a 3-arm single center study of 45 patients. These cohorts will include 15 breast patients scheduled to undergo a biopsy, and 15 thyroid patients scheduled to undergo fine needle aspiration, biopsy, or thyroidectomy that consent to undergo an acoustic angiography in conjunction with b-mode ultrasound prior to their scheduled biopsy. Prior to imaging clinical patients, the third arm will include 15 healthy volunteers that will be imaged to optimize imaging parameters.
- Detailed Description
Increasing the sensitivity and specificity of diagnostic imaging in patients at high risk for breast or thyroid 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 27
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Breast Imaging Cohort Acoustic Angiography A total of 15 women with known breast lesions that are already scheduled to undergo a clinical biopsy Thyroid Imaging Cohort Acoustic Angiography A total of 15 participants with known thyroid lesions that are already scheduled to undergo a clinical biopsy Healthy Volunteers Cohort Acoustic Angiography A total of 15 participants will be included to optimize imaging parameters. Breast Imaging Cohort Definity A total of 15 women with known breast lesions that are already scheduled to undergo a clinical biopsy Thyroid Imaging Cohort Definity A total of 15 participants with known thyroid lesions that are already scheduled to undergo a clinical biopsy Healthy Volunteers Cohort Definity A total of 15 participants will be included to optimize imaging parameters.
- Primary Outcome Measures
Name Time Method Sensitivity of Acoustic Angiography; Thyroid Imaging (percent of positive scans) Calculated once all imaging is complete [Anticipated 1.5 years] Sensitivity of Acoustic Angiography in the analysis of know thyroid lesions will be evaluated by comparing image analyses to the pathological results for these lesions.
Specificity of Acoustic Angiography; Thyroid Imaging (percent of negative scans) Calculated once all imaging is complete [Anticipated 1.5 years] Specificity of Acoustic Angiography in the analysis of know thyroid lesions will be evaluated by comparing image analyses to the pathological results for these lesions.
Sensitivity of Acoustic Angiography; Breast Imaging (percent of positive scans) Calculated once all imaging is complete [Anticipated 1.5 years] Sensitivity of Acoustic Angiography in the analysis of know breast lesions will be evaluated by comparing image analyses to the pathological results for these lesions.
Specificity of Acoustic Angiography; Breast Imaging (percent of negative scans) Calculated once all imaging is complete [Anticipated 1.5 years] Specificity of Acoustic Angiography in the analysis of know breast lesions will be evaluated by comparing image analyses to the pathological results for these lesions.
- Secondary Outcome Measures
Name Time Method Radiologist preference (Arbitrary units) Calculated once all imaging is complete [Anticipated 1.5 years] To compare radiologist preference of acoustic angiography to conventional b-mode ultrasound for each lesion characteristic (shape, margins, and vascularity)
Area Under the Curve of Acoustic Angiography (arbitrary units) Calculated once all imaging is complete [Anticipated 1.5 years] To compare the area under the curve (AUC) of acoustic angiography to the AUC of the b-mode ultrasound
Sensitivity of acoustic angiography compared to conventional ultrasound: Thyroid (arbitrary units) Calculated once all imaging is complete [Anticipated 1.5 years] To compare (using a reader study) the sensitivity of acoustic angiography to the sensitivity of conventional b-mode ultrasound in evaluation of known thyroid lesions for predicting malignancy.
Specificity of acoustic angiography compared to conventional ultrasound: Thyroid (arbitrary units) Calculated once all imaging is complete [Anticipated 1.5 years] To compare (using a reader study) the specificity of acoustic angiography to the specificity of conventional b-mode ultrasound in evaluation of known thyroid lesions for predicting malignancy.
Sensitivity of acoustic angiography compared to conventional ultrasound: Breast (arbitrary units) Calculated once all imaging is complete [Anticipated 1.5 years] To compare (using a reader study) the sensitivity of acoustic angiography to the sensitivity of conventional b-mode ultrasound in evaluation of known breast lesions for predicting malignancy.
Specificity of acoustic angiography compared to conventional ultrasound: Breast (arbitrary units) Calculated once all imaging is complete [Anticipated 1.5 years] To compare (using a reader study) the specificity of acoustic angiography to the specificity of conventional b-mode ultrasound in evaluation of known breast lesions for predicting malignancy.
Trial Locations
- Locations (1)
Univeristy of North Carolina Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States