Contrast-enhanced Ultrasound as a Screening Tool for Kidney Cancer in Patients With Von-Hippel Lindau
Von-Hippel Lindau · Kidney Disease, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT03907657 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Perflutren lipid microsphere (Drug); Sulfur hexafluoride lipid microspheres (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison in Radiologist's Lesion Evaluation: CEUS Versus B-mode Ultrasound |
0.13; 0.20 | — |
| SECONDARY Comparison in Radiologist's Lesion Evaluation: CEUS Versus Clinically Performed MRI |
0.13; 0.10 | — |
Summary
Eligibility Criteria
Inclusion Criteria
To be eligible for the present study, patients must meet the following criteria:
- Able to provide written informed consent
- Willing to comply with protocol requirements
- At least 16 years of age
- Carry a diagnosis of VHL and able to undergo routine clinical screening tests for RCC
Exclusion Criteria
- Critically ill or medically unstable or in an intensive care setting and whose critical course during the 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
- 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.
- 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
- Female patient who is pregnant or lactating
- Obesity that limits obtainment of acceptable images
Data sourced from ClinicalTrials.gov (NCT03907657). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.