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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA220681 | U.S. NIH Grant/Contract | View source |
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Grant ended
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Imaging Cohort | Experimental | A total of 15 women with known breast lesions that are already scheduled to undergo a clinical biopsy |
|
| Thyroid Imaging Cohort | Experimental | A total of 15 participants with known thyroid lesions that are already scheduled to undergo a clinical biopsy |
|
| Healthy Volunteers Cohort | Experimental | A total of 15 participants will be included to optimize imaging parameters. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Definity | Drug | Perflutren will be administered in split doses using the dosing range and administration type IV bolus) within the perflutren prescribing information. When administered as a bolus, the package insert recommends 10 uL/kg patient weight administered within 30-60 seconds, followed by a 10mL saline flush with a second dose of 10 uL/kg patient weight 30 minutes following the first dose, if needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of Acoustic Angiography; Breast Imaging | The sensitivity of Acoustic Angiography in the analysis of known breast lesions will be evaluated by comparing image analyses to the pathological results for these lesions. Sensitivity (%) = True Positives (TP)+False Negatives (FN)True Positives (TP) | Baseline |
| Specificity of Acoustic Angiography; Breast Imaging (Percent of Negative Scans) | Specificity of Acoustic Angiography in the analysis of known breast lesions will be evaluated by comparing image analyses to the pathological results for these lesions. Specificity was calculated based on the formula, which is true negative / (true negative + false positive). | Baseline |
| Sensitivity of Acoustic Angiography; Thyroid Imaging (Percent of Positive Scans) | 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. The study closed early due to insufficient funding and did not reach target enrollment. No participants were enrolled in Arm 2 (Thyroid Imaging); therefore, no outcome measure results are available. | Baseline |
| Specificity of Acoustic Angiography; Thyroid Imaging (Percent of Negative Scans) | Specificity of Acoustic Angiography in the analysis of known thyroid lesions will be evaluated by comparing image analyses to the pathological results for these lesions. The study closed early due to insufficient funding and did not reach target enrollment. No participants were enrolled in Arm 2 (Thyroid Imaging); therefore, no outcome measure results are available. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve of Acoustic Angiography (Arbitrary Units) | To compare the area under the curve (AUC) of acoustic angiography to the AUC of the B-mode ultrasound. Readers assigned a malignancy likelihood score from 1 to 5, with 1 likely benign to 5 likely malignant. An AUC was then calculated based on these scores. The Receiver operating curve (ROC ) was then plotted from this curve, and the AUC was estimated from the ROC curve. |
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Healthy Volunteers
Inclusion Criteria
Exclusion Criteria
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 perflutren lipid (Definity®)
Active cardiac disease including any of the following:
Breast Imaging Patients
Inclusion Criteria
Exclusion Criteria
Male
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)
Sonographically visible breast lesion larger than 2cm or greater than 3cm in depth from the skin surface
Known hypersensitivity to perflutren lipid (Definity®)
Active cardiac disease including any of the following:
Thyroid Imaging Patients Inclusion Criteria
Exclusion Criteria
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 perflutren lipid (Definity®)
Active cardiac disease including any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Yueh Lee, MD, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univeristy of North Carolina Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
Deidentified individual data that supports the results
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication.
An investigator who proposes to use the data must have approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.
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Twenty-eight participants consented to the study; one was ineligible and not enrolled. No participants were enrolled in Arm 2 (Thyroid Imaging). Twelve were enrolled in Arm 1 (Breast Imaging), and fifteen in Arm 3 (Healthy Volunteers).
Participants were recruited at a North Carolina cancer center from 04/11/2022 to 08/01/2024, with enrollment occurring between 05/26/2022 and 08/01/2024. The study closed before reaching its target enrollment due to insufficient funding.
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| ID | Title | Description |
|---|---|---|
| FG000 | Breast Imaging Cohort | Women with known breast lesions that are already scheduled to undergo a clinical biopsy. |
| FG001 | Thyroid Imaging Cohort | Participants with known thyroid lesions that are already scheduled to undergo a clinical biopsy. |
| FG002 | Healthy Volunteers Cohort | A total of 15 participants will be included to optimize imaging parameters. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All eligible participants who consented were included.
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| ID | Title | Description |
|---|---|---|
| BG000 | Breast Imaging Cohort | Women with known breast lesions that are already scheduled to undergo a clinical biopsy. |
| BG001 | Thyroid Imaging Cohort | Participants with known thyroid lesions that are already scheduled to undergo a clinical biopsy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensitivity of Acoustic Angiography; Breast Imaging | The sensitivity of Acoustic Angiography in the analysis of known breast lesions will be evaluated by comparing image analyses to the pathological results for these lesions. Sensitivity (%) = True Positives (TP)+False Negatives (FN)True Positives (TP) | Patients with known breast lesion. | Posted | Number | percentage | Baseline |
|
|
Adverse events were recorded from the day of imaging.
Adverse events were graded according to CTCAE on the day of research imaging.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Breast Imaging Cohort | Women with known breast lesions that are already scheduled to undergo a clinical biopsy, and acoustic angiography imaging will be performed by trained medical personnel using mild compression to eliminate motion. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| flushing | Vascular disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Desma Jones | UNC Lineberger Comprehensive Cancer Center | (919) 843-9463 | desma_jones@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 19, 2022 | Jul 12, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C042852 | perflutren |
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Acoustic angiography is a new type of contrast enhanced ultrasound imaging which is specifically sensitive to microvascular structure and density.
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|
|
| Acoustic Angiography | Device | Acoustic angiography imaging involves a research ultrasound scanner 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. Imaging will be performed within the package insert guidelines for ultrasound system mechanical index (a measurement of output power) when imaging perflutren contrast agent (less than 0.8). 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. |
|
| Baseline |
| Radiologist Preference (Arbitrary Units) | To compare radiologist preference of acoustic angiography (AA) to conventional b-mode ultrasound, for each lesion characteristics which are shape, margins, and vascularity, were examined. Radiologists rated their preferences on a Likert scale from 1 to 5, with 1 strongly preferring conventional ultrasound and 5 strongly preferring AA. Shape, margin, and vascularity values appear to represent mean or median rather than counts. We should select either the mean or the median and provide the standard deviation, which will be 0 if all radiologists assign the same score. | Baseline |
| Sensitivity of Acoustic Angiography Compared to Conventional Ultrasound: Breast (Arbitrary Units) | Sensitivity of Acoustic Angiography relative to conventional ultrasound in the analysis of known breast lesions will be evaluated by comparing image analyses to the pathological results for these lesions for both modalities. Sensitivity was calculated based on the formula, which is true positive / (true positive + false negative). The ratio between the sensitivity of AA over the sensitivity of conventional ultrasound was then calculated. | Baseline |
| Specificity of Acoustic Angiography Compared to Conventional Ultrasound: Breast (Arbitrary Units) | Specificity of Acoustic Angiography (AA) and conventional ultrasound in the analysis of known breast lesions will be evaluated by comparing image analyses to the pathological results for these lesions for each modality. Specificity was calculated based on the formula, which is true negative / (true negative + false positive). The ratio between the sensitivity of AA over the sensitivity of conventional ultrasound was then calculated. | Baseline |
| Sensitivity of Acoustic Angiography Compared to Conventional Ultrasound: Thyroid (Arbitrary Units) | 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. The study closed early due to insufficient funding and did not reach target enrollment. No participants were enrolled in Arm 2 (Thyroid Imaging); therefore, no outcome measure results are available. | Baseline |
| Specificity of Acoustic Angiography Compared to Conventional Ultrasound: Thyroid (Arbitrary Units) | 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. The study closed early due to insufficient funding and did not reach target enrollment. No participants were enrolled in Arm 2 (Thyroid Imaging); therefore, no outcome measure results are available. | Calculated once all imaging is complete [Anticipated 1.5 years] |
| BG002 | Healthy Volunteers Cohort | A total of 15 participants will be included to optimize imaging parameters. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Specificity of Acoustic Angiography; Breast Imaging (Percent of Negative Scans) | Specificity of Acoustic Angiography in the analysis of known breast lesions will be evaluated by comparing image analyses to the pathological results for these lesions. Specificity was calculated based on the formula, which is true negative / (true negative + false positive). | Patient with known breast lesion. | Posted | Number | percentage of benign lesion | Baseline |
|
|
|
| Primary | Sensitivity of Acoustic Angiography; Thyroid Imaging (Percent of Positive Scans) | 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. The study closed early due to insufficient funding and did not reach target enrollment. No participants were enrolled in Arm 2 (Thyroid Imaging); therefore, no outcome measure results are available. | Posted | Baseline |
|
|
| Primary | Specificity of Acoustic Angiography; Thyroid Imaging (Percent of Negative Scans) | Specificity of Acoustic Angiography in the analysis of known thyroid lesions will be evaluated by comparing image analyses to the pathological results for these lesions. The study closed early due to insufficient funding and did not reach target enrollment. No participants were enrolled in Arm 2 (Thyroid Imaging); therefore, no outcome measure results are available. | Posted | Baseline |
|
|
| Secondary | Area Under the Curve of Acoustic Angiography (Arbitrary Units) | To compare the area under the curve (AUC) of acoustic angiography to the AUC of the B-mode ultrasound. Readers assigned a malignancy likelihood score from 1 to 5, with 1 likely benign to 5 likely malignant. An AUC was then calculated based on these scores. The Receiver operating curve (ROC ) was then plotted from this curve, and the AUC was estimated from the ROC curve. | Patient with a known breast lesion. | Posted | Number | percentage of probability | Baseline |
|
|
|
| Secondary | Radiologist Preference (Arbitrary Units) | To compare radiologist preference of acoustic angiography (AA) to conventional b-mode ultrasound, for each lesion characteristics which are shape, margins, and vascularity, were examined. Radiologists rated their preferences on a Likert scale from 1 to 5, with 1 strongly preferring conventional ultrasound and 5 strongly preferring AA. Shape, margin, and vascularity values appear to represent mean or median rather than counts. We should select either the mean or the median and provide the standard deviation, which will be 0 if all radiologists assign the same score. | Patients with a known breast lesion. | Posted | Median | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | Sensitivity of Acoustic Angiography Compared to Conventional Ultrasound: Breast (Arbitrary Units) | Sensitivity of Acoustic Angiography relative to conventional ultrasound in the analysis of known breast lesions will be evaluated by comparing image analyses to the pathological results for these lesions for both modalities. Sensitivity was calculated based on the formula, which is true positive / (true positive + false negative). The ratio between the sensitivity of AA over the sensitivity of conventional ultrasound was then calculated. | Patients with malignant breast lesion(s). | Posted | Number | ratio | Baseline |
|
|
|
| Secondary | Specificity of Acoustic Angiography Compared to Conventional Ultrasound: Breast (Arbitrary Units) | Specificity of Acoustic Angiography (AA) and conventional ultrasound in the analysis of known breast lesions will be evaluated by comparing image analyses to the pathological results for these lesions for each modality. Specificity was calculated based on the formula, which is true negative / (true negative + false positive). The ratio between the sensitivity of AA over the sensitivity of conventional ultrasound was then calculated. | Patients with known breast lesion(s). | Posted | Number | ratio | Baseline |
|
|
|
| Secondary | Sensitivity of Acoustic Angiography Compared to Conventional Ultrasound: Thyroid (Arbitrary Units) | 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. The study closed early due to insufficient funding and did not reach target enrollment. No participants were enrolled in Arm 2 (Thyroid Imaging); therefore, no outcome measure results are available. | Posted | Baseline |
|
|
| Secondary | Specificity of Acoustic Angiography Compared to Conventional Ultrasound: Thyroid (Arbitrary Units) | 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. The study closed early due to insufficient funding and did not reach target enrollment. No participants were enrolled in Arm 2 (Thyroid Imaging); therefore, no outcome measure results are available. | Posted | Calculated once all imaging is complete [Anticipated 1.5 years] |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Thyroid Imaging Cohort | Participants with known thyroid lesions that are already scheduled to undergo a clinical biopsy and acoustic angiography imaging will be performed by trained medical personnel using mild compression to eliminate motion. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Healthy Volunteers Cohort | Participants will be included to optimize imaging parameters. Acoustic angiography imaging will be performed by trained medical personnel using mild compression to eliminate motion. | 0 | 15 | 0 | 15 | 1 | 15 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| Title | Measurements |
|---|---|
|