Trial · NCT04136912
3-D Super Resolution Ultrasound Microvascular Imaging
NCT04136912, Phase 2, Terminated, UNC Lineberger Comprehensive Cancer Center; results first posted 2025-09-15
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. 3-D Super Resolution Ultrasound Microvascular Imaging. Trials, record NCT04136912. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04136912
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 3-D Super Resolution Ultrasound Microvascular Imaging
- NCT number
- NCT04136912
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Conditions
- Breast Cancer, Thyroid Cancer
- Interventions
- Definity, Acoustic Angiography
- First posted
- 2019-10-23
- Last updated
- 2025-10-06
- Results first posted
- 2025-09-15
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sensitivity of Acoustic Angiography; Breast Imaging | Baseline | 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) |
| Primary | Specificity of Acoustic Angiography; Breast Imaging (Percent of Negative Scans) | Baseline | 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). |
| Primary | Sensitivity of Acoustic Angiography; Thyroid Imaging (Percent of Positive Scans) | Baseline | 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. |
| Primary | Specificity of Acoustic Angiography; Thyroid Imaging (Percent of Negative Scans) | Baseline | 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. |
| Secondary | Area Under the Curve of Acoustic Angiography (Arbitrary Units) | Baseline | 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. |
| Secondary | Radiologist Preference (Arbitrary Units) | Baseline | 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. |
| Secondary | Sensitivity of Acoustic Angiography Compared to Conventional Ultrasound: Breast (Arbitrary Units) | Baseline | 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. |
| Secondary | Specificity of Acoustic Angiography Compared to Conventional Ultrasound: Breast (Arbitrary Units) | Baseline | 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. |
| Secondary | Sensitivity of Acoustic Angiography Compared to Conventional Ultrasound: Thyroid (Arbitrary Units) | Baseline | 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. |
| Secondary | 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. 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sensitivity of Acoustic Angiography; Breast Imaging | Baseline | Patients with known breast lesion. | percentage | NUMBER |
| PRIMARY | Specificity of Acoustic Angiography; Breast Imaging (Percent of Negative Scans) | Baseline | Patient with known breast lesion. | percentage of benign lesion | NUMBER |
| PRIMARY | Sensitivity of Acoustic Angiography; Thyroid Imaging (Percent of Positive Scans) | Baseline | |||
| PRIMARY | Specificity of Acoustic Angiography; Thyroid Imaging (Percent of Negative Scans) | Baseline | |||
| SECONDARY | Area Under the Curve of Acoustic Angiography (Arbitrary Units) | Baseline | Patient with a known breast lesion. | percentage of probability | NUMBER |
| SECONDARY | Radiologist Preference (Arbitrary Units) | Baseline | Patients with a known breast lesion. | score on a scale | MEDIAN |
| SECONDARY | Sensitivity of Acoustic Angiography Compared to Conventional Ultrasound: Breast (Arbitrary Units) | Baseline | Patients with malignant breast lesion(s). | ratio | NUMBER |
| SECONDARY | Specificity of Acoustic Angiography Compared to Conventional Ultrasound: Breast (Arbitrary Units) | Baseline | Patients with known breast lesion(s). | ratio | NUMBER |
| SECONDARY | Sensitivity of Acoustic Angiography Compared to Conventional Ultrasound: Thyroid (Arbitrary Units) | Baseline | |||
| SECONDARY | Specificity of Acoustic Angiography Compared to Conventional Ultrasound: Thyroid (Arbitrary Units) | Calculated once all imaging is complete [Anticipated 1.5 years] |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sensitivity of Acoustic Angiography; Breast Imaging | Breast Imaging Cohort | 50 | percentage | ||
| Specificity of Acoustic Angiography; Breast Imaging (Percent of Negative Scans) | Breast Imaging Cohort | 67 | percentage of benign lesion | ||
| Area Under the Curve of Acoustic Angiography (Arbitrary Units) | Breast Imaging Cohort | 50 | percentage of probability | ||
| Radiologist Preference (Arbitrary Units) | Breast Imaging Cohort | shape | 1 | Standard Deviation 0 | score on a scale |
| Radiologist Preference (Arbitrary Units) | Breast Imaging Cohort | margin | 1 | Standard Deviation 0 | score on a scale |
| Radiologist Preference (Arbitrary Units) | Breast Imaging Cohort | vascularity | 5 | Standard Deviation 0 | score on a scale |
| Sensitivity of Acoustic Angiography Compared to Conventional Ultrasound: Breast (Arbitrary Units) | Breast Imaging Cohort | 1.2 | ratio | ||
| Specificity of Acoustic Angiography Compared to Conventional Ultrasound: Breast (Arbitrary Units) | Breast Imaging Cohort | 0.86 | ratio |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Breast Imaging Cohort | 12 | |
| Overall Study | STARTED | Thyroid Imaging Cohort | 0 | |
| Overall Study | STARTED | Healthy Volunteers Cohort | 15 | |
| Overall Study | COMPLETED | Breast Imaging Cohort | 12 | |
| Overall Study | COMPLETED | Thyroid Imaging Cohort | 0 | |
| Overall Study | COMPLETED | Healthy Volunteers Cohort | 13 | |
| Overall Study | NOT COMPLETED | Breast Imaging Cohort | 0 | |
| Overall Study | NOT COMPLETED | Thyroid Imaging Cohort | 0 | |
| Overall Study | NOT COMPLETED | Healthy Volunteers Cohort | 2 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | flushing | Vascular disorders | Breast Imaging Cohort | 0 | 12 | |
| other | flushing | Vascular disorders | Thyroid Imaging Cohort | 0 | 0 | |
| other | flushing | Vascular disorders | Healthy Volunteers Cohort | 1 | 15 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Breast Imaging Cohort | 0 | 12 |
| Total, all-cause mortality | Thyroid Imaging Cohort | 0 | 0 |
| Total, all-cause mortality | Healthy Volunteers Cohort | 0 | 15 |
| Total, other adverse events | Breast Imaging Cohort | 0 | 12 |
| Total, other adverse events | Thyroid Imaging Cohort | 0 | 0 |
| Total, other adverse events | Healthy Volunteers Cohort | 1 | 15 |
| Total, serious adverse events | Breast Imaging Cohort | 0 | 12 |
| Total, serious adverse events | Thyroid Imaging Cohort | 0 | 0 |
| Total, serious adverse events | Healthy Volunteers Cohort | 0 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01CA220681 | High Frame Rate 3-D Super Resolution Ultrasound Microvascular Imaging | DAYTON, PAUL A; PINTON, GIANMARCO | UNIV OF NORTH CAROLINA CHAPEL HILL | NATIONAL CANCER INSTITUTE | 2017 to 2022 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04136912
GET https://conductscience.org/api/trials/v1/NCT04136912/registered