Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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 ultrasound and contrast-enhanced magnetic resonance imaging (MRI)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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