Trial Outcomes & Findings for 3-D Super Resolution Ultrasound Microvascular Imaging (NCT NCT04136912)
NCT ID: NCT04136912
Last Updated: 2025-10-06
Results Overview
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)
TERMINATED
PHASE2
27 participants
Baseline
2025-10-06
Participant Flow
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.
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).
Participant milestones
| Measure |
Breast Imaging Cohort
Women with known breast lesions that are already scheduled to undergo a clinical biopsy.
|
Thyroid Imaging Cohort
Participants with known thyroid lesions that are already scheduled to undergo a clinical biopsy.
|
Healthy Volunteers Cohort
A total of 15 participants will be included to optimize imaging parameters.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
0
|
15
|
|
Overall Study
COMPLETED
|
12
|
0
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Breast Imaging Cohort
Women with known breast lesions that are already scheduled to undergo a clinical biopsy.
|
Thyroid Imaging Cohort
Participants with known thyroid lesions that are already scheduled to undergo a clinical biopsy.
|
Healthy Volunteers Cohort
A total of 15 participants will be included to optimize imaging parameters.
|
|---|---|---|---|
|
Overall Study
Operational reasons
|
0
|
0
|
2
|
Baseline Characteristics
3-D Super Resolution Ultrasound Microvascular Imaging
Baseline characteristics by cohort
| Measure |
Breast Imaging Cohort
n=12 Participants
Women with known breast lesions that are already scheduled to undergo a clinical biopsy.
|
Thyroid Imaging Cohort
Participants with known thyroid lesions that are already scheduled to undergo a clinical biopsy.
|
Healthy Volunteers Cohort
n=15 Participants
A total of 15 participants will be included to optimize imaging parameters.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.83 years
STANDARD_DEVIATION 18.35 • n=5 Participants
|
—
|
29.73 years
STANDARD_DEVIATION 12.57 • n=5 Participants
|
41.17 years
STANDARD_DEVIATION 18.16 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
—
|
15 participants
n=5 Participants
|
27 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Patients with known breast lesion.
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)
Outcome measures
| Measure |
Breast Imaging Cohort
n=12 Participants
Women with known breast lesions that are already scheduled to undergo a clinical biopsy.
|
|---|---|
|
Sensitivity of Acoustic Angiography; Breast Imaging
|
50 percentage
|
PRIMARY outcome
Timeframe: BaselinePopulation: Patient with known breast lesion.
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).
Outcome measures
| Measure |
Breast Imaging Cohort
n=12 Participants
Women with known breast lesions that are already scheduled to undergo a clinical biopsy.
|
|---|---|
|
Specificity of Acoustic Angiography; Breast Imaging (Percent of Negative Scans)
|
67 percentage of benign lesion
|
PRIMARY outcome
Timeframe: BaselineSensitivity 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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: BaselineSpecificity 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: Patient with a known breast lesion.
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.
Outcome measures
| Measure |
Breast Imaging Cohort
n=12 Participants
Women with known breast lesions that are already scheduled to undergo a clinical biopsy.
|
|---|---|
|
Area Under the Curve of Acoustic Angiography (Arbitrary Units)
|
50 percentage of probability
|
SECONDARY outcome
Timeframe: BaselinePopulation: Patients with a known breast lesion.
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.
Outcome measures
| Measure |
Breast Imaging Cohort
n=12 Participants
Women with known breast lesions that are already scheduled to undergo a clinical biopsy.
|
|---|---|
|
Radiologist Preference (Arbitrary Units)
shape
|
1 score on a scale
Standard Deviation 0
|
|
Radiologist Preference (Arbitrary Units)
margin
|
1 score on a scale
Standard Deviation 0
|
|
Radiologist Preference (Arbitrary Units)
vascularity
|
5 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: BaselinePopulation: Patients with malignant breast lesion(s).
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.
Outcome measures
| Measure |
Breast Imaging Cohort
n=12 Participants
Women with known breast lesions that are already scheduled to undergo a clinical biopsy.
|
|---|---|
|
Sensitivity of Acoustic Angiography Compared to Conventional Ultrasound: Breast (Arbitrary Units)
|
1.2 ratio
|
SECONDARY outcome
Timeframe: BaselinePopulation: Patients with known breast lesion(s).
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.
Outcome measures
| Measure |
Breast Imaging Cohort
n=12 Participants
Women with known breast lesions that are already scheduled to undergo a clinical biopsy.
|
|---|---|
|
Specificity of Acoustic Angiography Compared to Conventional Ultrasound: Breast (Arbitrary Units)
|
0.86 ratio
|
SECONDARY outcome
Timeframe: BaselineTo 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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. 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.
Outcome measures
Outcome data not reported
Adverse Events
Breast Imaging Cohort
Thyroid Imaging Cohort
Healthy Volunteers Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Breast Imaging Cohort
n=12 participants at risk
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.
|
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.
|
Healthy Volunteers Cohort
n=15 participants at risk
Participants will be included to optimize imaging parameters. Acoustic angiography imaging will be performed by trained medical personnel using mild compression to eliminate motion.
|
|---|---|---|---|
|
Vascular disorders
flushing
|
0.00%
0/12 • Adverse events were recorded from the day of imaging.
Adverse events were graded according to CTCAE on the day of research imaging.
|
—
0/0 • Adverse events were recorded from the day of imaging.
Adverse events were graded according to CTCAE on the day of research imaging.
|
6.7%
1/15 • Adverse events were recorded from the day of imaging.
Adverse events were graded according to CTCAE on the day of research imaging.
|
Additional Information
Desma Jones
UNC Lineberger Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place