Overview

Contrast-enhanced Ultrasound as a Screening Tool for Kidney Cancer in Patients With Von-Hippel Lindau

Status:
Recruiting
Trial end date:
2022-06-01
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 Von-Hippel Lindau 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
Collaborators:
Lantheus Medical Imaging
Vanderbilt University
Criteria
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