Trial · NCT02684435
Contrast-enhanced Ultrasound of the Kidney
NCT02684435, Phase 2, Completed, University of North Carolina, Chapel Hill; results first posted 2019-07-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Contrast-enhanced Ultrasound of the Kidney. Trials, record NCT02684435. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02684435
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Contrast-enhanced Ultrasound of the Kidney
- NCT number
- NCT02684435
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 63 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Chronic Kidney Disease, Cystic Kidney Disease
- Interventions
- Perflutren lipid microsphere
- First posted
- 2016-02-18
- Last updated
- 2019-09-26
- Results first posted
- 2019-07-02
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Lesions With a Change in Radiologist's Evaluation | Baseline, 1 year | Lesions will be assessed for change in size, calcification, and septation based on Bosniak criteria (I, II, IIF, III, IV) to determine whether a lesion has progressed, regressed, or is stable. |
| Primary | Sensitivity of Qualitative Interpretations of CEUS in Diagnosing Kidney Malignancy | Baseline, 1 year | PRELIMINARY RESULTS of sensitivity of qualitative interpretations of CEUS in diagnosing kidney malignancy in patients with CKD and a suspicious or indeterminate lesion on non-contrasted imaging compared to the truth standard |
| Primary | Specificity of Qualitative Interpretations of CEUS | Baseline, 1 year | PRELIMINARY RESULTS of specificity of qualitative interpretations of CEUS in diagnosing kidney malignancy in patients with CKD and a suspicious or indeterminate lesion on non-contrasted imaging compared to the truth standard |
| Secondary | Specificity of Quantitative Metrics Generated From CEUS in Diagnosing Kidney Malignancy in Patients With CKD and a Suspicious or Indeterminate Lesion on Non-contrasted Imaging Compared to the Truth Standard | Baseline, 1 Year | Specificity of Quantitative Metrics Generated From CEUS in Diagnosing Kidney Malignancy in Patients With CKD and a Suspicious or Indeterminate Lesion on Non-contrasted Imaging Compared to the Truth Standard |
| Secondary | Sensitivity of Quantitative Metrics Generated From CEUS in Diagnosing Kidney Malignancy in Patients With CKD and a Suspicious or Indeterminate Lesion on Non-contrasted Imaging Compared to the Truth Standard | Baseline, 1 Year | Sensitivity of Quantitative Metrics Generated From CEUS in Diagnosing Kidney Malignancy in Patients With CKD and a Suspicious or Indeterminate Lesion on Non-contrasted Imaging Compared to the Truth Standard |
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 | Number of Lesions With a Change in Radiologist's Evaluation | Baseline, 1 year | lesions | NUMBER | |
| PRIMARY | Sensitivity of Qualitative Interpretations of CEUS in Diagnosing Kidney Malignancy | Baseline, 1 year | percentage of positive scans | NUMBER | |
| PRIMARY | Specificity of Qualitative Interpretations of CEUS | Baseline, 1 year | percentage of negative scans | NUMBER | |
| SECONDARY | Specificity of Quantitative Metrics Generated From CEUS in Diagnosing Kidney Malignancy in Patients With CKD and a Suspicious or Indeterminate Lesion on Non-contrasted Imaging Compared to the Truth Standard | Baseline, 1 Year | Quantitative analysis unable to be conducted on cystic lesions and required solid portions, so data was not collected | ||
| SECONDARY | Sensitivity of Quantitative Metrics Generated From CEUS in Diagnosing Kidney Malignancy in Patients With CKD and a Suspicious or Indeterminate Lesion on Non-contrasted Imaging Compared to the Truth Standard | Baseline, 1 Year | Quantitative analysis unable to be conducted on cystic lesions and required solid portions, so data was not collected |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Lesions With a Change in Radiologist's Evaluation | Perflutren Lipid Microsphere | 24 | lesions | ||
| Sensitivity of Qualitative Interpretations of CEUS in Diagnosing Kidney Malignancy | Perflutren Lipid Microsphere | 75 | percentage of positive scans | ||
| Specificity of Qualitative Interpretations of CEUS | Perflutren Lipid Microsphere | 71 | percentage of negative scans |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Perflutren Lipid Microsphere | 63 | 64 |
| Overall Study | COMPLETED | Perflutren Lipid Microsphere | 63 | 64 |
| Overall Study | NOT COMPLETED | Perflutren Lipid Microsphere | 0 | 0 |
Source ClinicalTrials.gov
Adverse events1
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 | Bilateral back pain that resolved by the time of discharge. | Musculoskeletal and connective tissue disorders | Perflutren Lipid Microsphere | 1 | 63 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Perflutren Lipid Microsphere | 0 | 63 |
| Total, other adverse events | Perflutren Lipid Microsphere | 1 | 63 |
| Total, serious adverse events | Perflutren Lipid Microsphere | 0 | 63 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
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/NCT02684435
GET https://conductscience.org/api/trials/v1/NCT02684435/registered