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

NCT03907657 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: LCCC1824
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Von-Hippel Lindau; Kidney Disease, Chronic

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline

Secondary Outcomes (1)

• Comparison in Radiologist's Lesion Evaluation: CEUS Versus Clinically Performed MRI

  Baseline

Study Arms (1)

Perflutren Lipid Microsphere or Lumason

EXPERIMENTAL

Patients with Von-Hippel Lindau disease will be imaged using contrast-enhanced ultrasound with either perflutren or Lumason.

Drug: Perflutren lipid microsphere; Drug: Sulfur hexafluoride lipid microspheres

Interventions

Perflutren lipid microsphere DRUG

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.

Also known as: • Definity®, • Microbubble contrast agent

Perflutren Lipid Microsphere or Lumason

Sulfur hexafluoride lipid microspheres DRUG

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.

Also known as: Lumason

Perflutren Lipid Microsphere or Lumason

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Lantheus Medical Imaging: collaborator

Study Sites (1)

University of North Carolina of Chapel hill

Chapel Hill, North Carolina, 27599-7510, United States

Location

Related Publications (1)

• Larcher 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 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

perflutren

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Melahat Canter
• Organization: University of North Carolina Lineberger Comprehensive Cancer Center

melahat.garipagaoglu@gmail.com

9199620000

Study Officials

• Emily Chang, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 9, 2019
• Study Start: September 23, 2019
• Primary Completion: March 13, 2023
• Study Completion: March 13, 2023
• Last Updated: May 21, 2024
• Results First Posted: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)