Trial · NCT03544268
Academic-Industrial Partnership for Translation of Acoustic Angiography
NCT03544268, Phase 4, Completed, UNC Lineberger Comprehensive Cancer Center; results first posted 2022-04-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Academic-Industrial Partnership for Translation of Acoustic Angiography. Trials, record NCT03544268. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03544268
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Academic-Industrial Partnership for Translation of Acoustic Angiography
- NCT number
- NCT03544268
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 20 participants, actual
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Conditions
- Signs and Symptoms
- Interventions
- Acoustic Angiography, Definity
- First posted
- 2018-06-01
- Last updated
- 2022-04-01
- Results first posted
- 2022-04-01
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sensitivity and Specificity | 2 years | 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 |
| Secondary | Area Under the Curve (AUC) of Acoustic Angiography | 2 years | To compare the area under the curve (AUC) of acoustic angiography to the AUC of the b-mode ultrasound To compare radiologist preference of acoustic angiography to conventional b-mode ultrasound for each lesion characteristic (shape, margins, and vascularity) Primary Endpoint Sensitivity and specificity for our study is defined as the ability of readers (radiologists) to use the acoustic angiography or b-mode ultrasound to distinguish between malignant and non-malignant breast lesions known to exist based on pathological results (the gold standard). The AUC of acoustic angiography compared to the AUC of b-mode ultrasound |
| Secondary | Radiologist Preference | 2 years | To compare radiologist preference of acoustic angiography to conventional b-mode ultrasound for each lesion characteristic (shape, margins and vascularity) |
| Secondary | Vessel Tortuosity (No Units) | 2 years | 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) |
| Secondary | Model-based Malignancy Score (Arbitrary Units) | 2 years | To compare the model-based malignancy score to the acoustic angiography reader study |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sensitivity and Specificity | 2 years | The data were unable to be analyzed because we could not visualize the vessels to calculate this value. The system was unable to achieve the imaging resolution to visualize the vasculature. | ||
| SECONDARY | Area Under the Curve (AUC) of Acoustic Angiography | 2 years | The data were unable to be analyzed because we could not visualize the vessels to calculate this value. The system was unable to achieve the imaging resolution to visualize the vasculature. | ||
| SECONDARY | Radiologist Preference | 2 years | The data were unable to be analyzed because we could not visualize the vessels to calculate this value. The system was unable to achieve the imaging resolution to visualize the vasculature. | ||
| SECONDARY | Vessel Tortuosity (No Units) | 2 years | The data were unable to be analyzed because we could not visualize the vessels to calculate this value. The system was unable to achieve the imaging resolution to visualize the vasculature. | ||
| SECONDARY | Model-based Malignancy Score (Arbitrary Units) | 2 years | The data were unable to be analyzed because we could not visualize the vessels to calculate this value. The system was unable to achieve the imaging resolution to visualize the vasculature. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Acoustic Angiography | 5 | |
| Overall Study | STARTED | Image Optimization | 15 | |
| Overall Study | COMPLETED | Acoustic Angiography | 3 | |
| Overall Study | COMPLETED | Image Optimization | 15 | |
| Overall Study | NOT COMPLETED | Acoustic Angiography | 2 | |
| Overall Study | NOT COMPLETED | Image Optimization | 0 |
Source ClinicalTrials.gov
Adverse events2
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 | Blood and lymphatic system disorders | Acoustic Angiography | 0 | 3 | |
| other | Flushing | Blood and lymphatic system disorders | Image Optimization | 3 | 15 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Acoustic Angiography | 0 | 3 |
| Total, all-cause mortality | Image Optimization | 0 | 15 |
| Total, other adverse events | Acoustic Angiography | 0 | 3 |
| Total, other adverse events | Image Optimization | 3 | 15 |
| Total, serious adverse events | Acoustic Angiography | 0 | 3 |
| Total, serious adverse events | Image Optimization | 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 |
|---|---|---|---|---|---|
| R01CA189479 | Academic-Industrial Partnership for Translation of Acoustic Angiography | DAYTON, PAUL A | UNIV OF NORTH CAROLINA CHAPEL HILL | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Acoustic Angiography vs Image Optimization: deaths from any cause | Trial comparisons |
| Acoustic Angiography vs Image Optimization: serious adverse events | Trial comparisons |
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/NCT03544268
GET https://conductscience.org/api/trials/v1/NCT03544268/registered