| Trial ID: | L0297 |
| Source ID: | NCT02684435
|
| Associated Drug: |
Perflutren Lipid Microsphere
|
| Title: |
Contrast-enhanced Ultrasound of the Kidney
|
| Acronym: |
CEUS-CKD
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02684435/results
|
| Conditions: |
Chronic Kidney Disease|Cystic Kidney Disease
|
| Interventions: |
DRUG: Perflutren lipid microsphere
|
| Outcome Measures: |
Primary: Number of Lesions With a Change in Radiologist's Evaluation, 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., Baseline, 1 year|Sensitivity of Qualitative Interpretations of CEUS in Diagnosing Kidney Malignancy, 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, Baseline, 1 year|Specificity of Qualitative Interpretations of CEUS, 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, Baseline, 1 year | 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, 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|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, 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
|
| Sponsor/Collaborators: |
Sponsor: University of North Carolina, Chapel Hill | Collaborators: Vanderbilt University|North Carolina Translational and Clinical Sciences Institute
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
63
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
|
| Start Date: |
2016-02
|
| Completion Date: |
2018-07-09
|
| Results First Posted: |
2019-07-02
|
| Last Update Posted: |
2019-09-26
|
| Locations: |
University of North Carolina of Chapel hill, Chapel Hill, North Carolina, 27599-7510, United States|Vanderbilt University, Nashville, Tennessee, 37232, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02684435
|
