Clinical trial · Interventional
Contrast-enhanced Ultrasound as a Screening Tool for Kidney Cancer in Patients With Von-Hippel Lindau
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
NCT03907657CI-TRIAL-00077346CEUS-VHLcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Disease, Chronic | — | UNRESOLVED | — |
| Von-Hippel Lindau | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Perflutren lipid microsphere | Drug | — | UNRESOLVED |
| Sulfur hexafluoride lipid microspheres | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Perflutren Lipid Microsphere or Lumason
- description
- Patients with Von-Hippel Lindau disease will be imaged using contrast-enhanced ultrasound with either perflutren or Lumason.
- interventionNames
- Drug: Perflutren lipid microsphere
- Drug: Sulfur hexafluoride lipid microspheres
Primary outcomes (1)
- measure
- Comparison in Radiologist's Lesion Evaluation: CEUS Versus B-mode Ultrasound
- timeFrame
- Baseline
- description
- Each reader will evaluate kidney imaging using Contrast-Enhanced Ultrasound (CEUS) versus Brightness Mode Ultrasound (B-mode) in patients at risk for kidney lesions. A dichotomized Bosniak score was used for comparison. Dichotomized Bosniak score: 0= nonmalignant and 1=malignant or possibly malignant. Scores were averaged across all readers. Kidneys were assessed by CEUS and B-mode by three different readers.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLarcher A, Rowe I, Belladelli F, Fallara G, Raggi D, Necchi A, Montorsi F, Capitanio U, Salonia A; OSR VHL Program. Von Hippel-Lindau disease-associated renal cell carcinoma: a call to action. Curr Opin Urol. 2022 Jan 1;32(1):31-39. doi: 10.1097/MOU.0000000000000950. PMID 34783716