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Perflutren lipid microsphere for Von Hippel-Lindau Disease (CEUS-VHL Trial)

Phase 2

Waitlist Available

Led By Emily Chang, MD

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up (baseline, 4 months)

Awards & highlights

CEUS-VHL Trial Summary

This trial will test whether contrast-enhanced ultrasound can detect kidney lesions in patients with Von-Hippel Lindau as accurately as MRI.

Eligible Conditions

Von Hippel-Lindau Disease
Chronic Kidney Disease

CEUS-VHL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ (baseline, 4 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~(baseline, 4 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and (baseline, 4 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Radiologist's Lesion Evaluation compared to B-mode Ultrasound (percent)

Secondary outcome measures

Change in Radiologist's Lesion Evaluation compared to contrasted MRI (percent)

CEUS-VHL Trial Design

1Treatment groups

Experimental Treatment

Group I: Perflutren Lipid Microsphere or LumasonExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sulfur hexafluoride lipid microspheres

2019

Completed Phase 2

~40

Perflutren lipid microsphere

2016

Completed Phase 2

~110

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor

351 Previous Clinical Trials

88,317 Total Patients Enrolled

Lantheus Medical ImagingIndustry Sponsor

56 Previous Clinical Trials

4,332,661 Total Patients Enrolled

Emily Chang, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

1 Previous Clinical Trials

25 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age requirement of this medical experiment limited to those under 25?

"Per the requirements of this trial, prospective participants must range in age between 16 and 99."

Answered by AI

What is the scope of participation in this clinical experiment?

"Affirmative. Clinicaltrials.gov indicates that the study, which was initially posted on September 23rd 2019, is actively seeking participants. The research necessitates 15 people to take part at a single medical site."

Answered by AI

For whom is eligibility available to take part in this clinical experiment?

"Fifteen individuals aged 16 to 99, suffering from chronic renal diseases, are being sought for this research project. It is imperative that the volunteers meet other requirements such as agreeing to adhere with protocol regulations and having reached at least the age of consent."

Answered by AI

What therapeutic applications is Perflutren lipid microsphere typically used for?

"Primarily used to facilitate echocardiography, perflutren lipid microsphere also has therapeutic potential for cardiovascular diseases and ultrasonography."

Answered by AI

Has the FDA granted approval for Perflutren lipid microsphere?

"Drawing from the existing evidence base, our team at Power signaled a rating of 2 for the safety profile of Perflutren lipid microsphere. This is due to available data that provides support for safety but not yet efficacy."

Answered by AI

Is the enrollment period open for this experiment?

"According to clinicaltrials.gov, recruitment for this trial is actively underway and has been since September 23rd 2019, with the latest update occuring on August 5th 2022."

Answered by AI

What prior investigations have been conducted on Perflutren lipid microsphere?

"As of now, 31 live trials researching Perflutren lipid microsphere are underway with 3 studies in Phase 3. Predominantly occurring in Philadelphia, Pennsylvania, these investigations span 42 locations around the globe."

Answered by AI

Recent research and studies

Current Opinion in UrologyJournal

Von Hippel–lindau Disease-associated Renal Cell Carcinoma: A Call to Action

Larcher, Alessandro, Isaline Rowe, Federico Belladelli, Giuseppe Fallara, Daniele Raggi, Andrea Necchi, Francesco Montorsi, Umberto Capitanio, and Andrea Salonia. 2021. “Von Hippel–lindau Disease-associated Renal Cell Carcinoma: A Call to Action”. Current Opinion in Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/mou.0000000000000950.

Current Opinion in UrologyJournal

Von Hippel–lindau Disease-associated Renal Cell Carcinoma: A Call to Action

clinicaltrials.govStudy

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

2019. "Contrast-enhanced Ultrasound as a Screening Tool for Kidney Cancer in Patients With Von-Hippel Lindau". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03907657.