Status:
COMPLETED
Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Conditions:
Kidney Cancer
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if contrast-enhanced ultrasound can detect abnormal features of kidney lesions in patients with suspected kidney cancer with the same accuracy as conventional...
Detailed Description
This is a pilot cross-sectional study that compares contrast enhanced ultrasound to conventional ultrasound and contrasted MRI. Eligible patients will include anyone who has suspected kidney cancer an...
Eligibility Criteria
Inclusion
- A suspected diagnosis of kidney cancer with a solid or partially solid lesion and planned surgical nephrectomy within 3 months before surgery
- Able to provide informed consent
- Willing to comply with protocol requirements
- At least 18 years of age
Exclusion
- Critically ill or medically unstable or in an intensive care setting and whose critical course during a potential observation period would be unpredictable
- Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®) or sulfur hexafluoride (Lumason®)
- Right to left shunt, severe pulmonary hypertension (Pulmonary artery pressure \>90mmHg), or adult respiratory distress syndrome
- Has any other medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data or of achieving the study objectives
- Unstable cardiopulmonary disease including any of the following:
- Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association)
- Unstable angina
- Symptomatic arrhythmia (i.e. tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia, atrial flutter or fibrillation)
- Myocardial infarction within 14 days prior to the date of proposed microbubble administration.
- Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine β-HCG results, obtained the same day as the CEUS, or on the basis of patient history, e.g.: tubal ligation, hysterectomy or a minimum of 1 year without menses)
- Obesity that limits obtainment of acceptable images
Key Trial Info
Start Date :
October 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04021238
Start Date
October 7 2020
End Date
August 5 2022
Last Update
November 13 2023
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599