Clinical trial

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

Name

LCCC1824

Description

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)

Trial arms

Trial start

2019-09-23

Estimated PCD

2023-03-13

Trial end

2023-03-13

Status

Completed

Phase

Early phase I

Treatment

Perflutren lipid microsphere

Baseline B-mode US will be performed to confirm the lesions being imaged (unless it is a subject with no lesions, then a basic B-mode US will be performed. Perflutren is a diagnostic drug that is intended to be used for contrast enhancement. The vial contains a clear, colorless, sterile, non-pyrogenic, hypertonic solution which is activated by mechanical agitation with Vialmix®.It will be dispensed in inactivated form to a study team member. The contrast agent will be activated just prior to administration (ideally to be used within 5 minutes of activation). Contrast agent Definity (or Lumason) will be activated according to package insert instructions, including use of VialMix®, the device used to activate Definity. Administration will occur IV in coordination with sonography staff trained specifically in contrast ultrasound imaging.The total imaging time is anticipated to be less than 30 minutes.

Arms:

Perflutren Lipid Microsphere or Lumason

Other names:

• Definity®, • Microbubble contrast agent

Sulfur hexafluoride lipid microspheres

Baseline B-mode US will be performed to confirm the lesions being imaged (unless it is a subject with no lesions, then a basic B-mode US will be performed. Lumason will be used as a secondary contrast agent only if Definity(perflutren) is unavailable.This drug will be administered using the dosing range and administration type within the Lumason prescribing information. The contrast agent will be activated just prior to administration (ideally to be used within 5 minutes of activation). Contrast agent Definity (or Lumason) will be activated according to package insert instructions, including use of VialMix®, the device used to activate Definity. Administration will occur IV in coordination with sonography staff trained specifically in contrast ultrasound imaging.The total imaging time is anticipated to be less than 30 minutes.

Arms:

Perflutren Lipid Microsphere or Lumason

Other names:

Lumason

Size

Primary endpoint

Comparison in Radiologist's Lesion Evaluation: CEUS Versus B-mode Ultrasound

Baseline

Eligibility 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

Protocol

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Updated at

2024-05-21

1 organization

2 products

3 indications

Organization

UNC Lineberger Comprehensive Cancer Center

Product

Perflutren lipid microsphere

Indication

Von Hippel Lindau

Indication

Chronic Kidney Disease

Indication

Chronic

Product

Sulfur hexafluoride