Kidney Disease, Chronic Clinical Trial
— CEUS-VHLOfficial title:
Double-Center Cross-Sectional Study of Contrast-Enhanced Ultrasound With Lumason/Definity as a Screening Tool for Kidney Cancer in Patients With Von-Hippel Lindau
Verified date | March 2023 |
Source | UNC Lineberger Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine if contrast-enhanced ultrasound can detect abnormal features of kidney lesions in patients with Von-Hippel Lindau with the same accuracy as conventional ultrasound and contrast-enhanced magnetic resonance imaging (MRI)
Status | Completed |
Enrollment | 15 |
Est. completion date | March 13, 2023 |
Est. primary completion date | March 13, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 99 Years |
Eligibility | Inclusion Criteria: To be eligible for the present study, patients must meet the following criteria: 1. Able to provide written informed consent 2. Willing to comply with protocol requirements 3. At least 16 years of age 4. Carry a diagnosis of VHL and able to undergo routine clinical screening tests for RCC Exclusion Criteria: 1. Critically ill or medically unstable or in an intensive care setting and whose critical course during the observation period would be unpredictable 2. Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®) or sulfur hexafluoride (Lumason®) 3. Right to left shunt, severe pulmonary hypertension (Pulmonary artery pressure >90mmHg), or adult respiratory distress syndrome 4. Active cardiac disease including any of the following: A. Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association) B.Unstable angina. C.Symptomatic arrhythmia (i.e. tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia, atrial flutter or fibrillation). D.Myocardial infarction within 14 days prior to the date of proposed microbubble administration. 5. Has any other medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data or of achieving the study objectives such as: - Mental illness - Drug abuse 6. Female patient who is pregnant or lactating 7. Obesity that limits obtainment of acceptable images |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina of Chapel hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
UNC Lineberger Comprehensive Cancer Center | Lantheus Medical Imaging |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Radiologist's Lesion Evaluation compared to B-mode Ultrasound (percent) | Kappas will be calculated separately for each reader for CEUS versus B-mode US using the dichotomized Bosniak score. Confidence intervals for kappas will be computed by bootstrapping subjects, accounting for potential correlations of kidneys within subjects. Differences in agreement between readers will be based on comparing reader specific kappas, with statistical significance of these differences tested via bootstrapping. An overall kappa will be computed for each paired imaging comparison by averaging kappas across readers, with a 95% interval calculated via bootstrapping. Differences in overall kappas for the 3 paired imaging comparisons will be assessed using a bootstrap test. | (Baseline) | |
Secondary | Change in Radiologist's Lesion Evaluation compared to contrasted MRI (percent) | Kappas will be calculated separately for each reader for CEUS versus contrasted MRI using the dichotomized Bosniak score. Confidence intervals for kappas will be computed by bootstrapping subjects, accounting for potential correlations of kidneys within subjects. Differences in agreement between readers will be based on comparing reader specific kappas, with statistical significance of these differences tested via bootstrapping. An overall kappa will be computed for each paired imaging comparison by averaging kappas across readers, with a 95% interval calculated via bootstrapping. Differences in overall kappas for the 3 paired imaging comparisons will be assessed using a bootstrap test. | (Baseline, 4 months) |
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