- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03907657
Contrast-enhanced Ultrasound as a Screening Tool for Kidney Cancer in Patients With Von-Hippel Lindau (CEUS-VHL)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a pilot cross-sectional study that compares contrast enhanced ultrasound to conventional ultrasound and contrasted MRI. Any patient undergoing annual imaging screening is eligible, but the investigators will target inclusion of at least 10 subjects who have at least 1 kidney lesion. Therefore, up to 5 subjects may have no current kidney lesions. Subject participation will be only for the day of CEUS study. There will be no follow-up period for this study. However, if results are encouraging, a longitudinal observational study may follow, and these same subjects would be eligible for enrollment. Eligible subjects will undergo a contrast enhanced ultrasound.
Following completion of imaging, all CEUS, MRI (within 4 months) and B-mode (at time of CEUS) US studies will be de-identified. Blinded radiologists will interpret images and provide an overall assessment of risk of malignancy to each kidney using the Bosniak criteria for each kidney lesion present. The Bosniak criteria places cystic lesions into one of 5 categories (I, II, IIF, III and IV) based on lesion characteristics. CEUS based diagnosis will be compared to the diagnoses on routine B-mode US and contrast-enhanced MRI.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Carly Sronce, RN-BC
- Phone Number: 919-966-3262
- Email: carly_sronce@med.unc.edu
Study Contact Backup
- Name: Desma Jones, BS,CCRC
- Phone Number: 919-843-9463
- Email: desma_jones@med.unc.edu
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599-7510
- University of North Carolina of Chapel hill
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Perflutren Lipid Microsphere or Lumason
Patients with Von-Hippel Lindau disease will be imaged using contrast-enhanced ultrasound with either perflutren or Lumason.
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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.
Other Names:
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Radiologist's Lesion Evaluation compared to B-mode Ultrasound (percent)
Time Frame: (Baseline)
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Kappas will be calculated separately for each reader for CEUS versus B-mode US using the dichotomized Bosniak score.
Confidence intervals for kappas will be computed by bootstrapping subjects, accounting for potential correlations of kidneys within subjects.
Differences in agreement between readers will be based on comparing reader specific kappas, with statistical significance of these differences tested via bootstrapping.
An overall kappa will be computed for each paired imaging comparison by averaging kappas across readers, with a 95% interval calculated via bootstrapping.
Differences in overall kappas for the 3 paired imaging comparisons will be assessed using a bootstrap test.
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(Baseline)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Radiologist's Lesion Evaluation compared to contrasted MRI (percent)
Time Frame: (Baseline, 4 months)
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Kappas will be calculated separately for each reader for CEUS versus contrasted MRI using the dichotomized Bosniak score.
Confidence intervals for kappas will be computed by bootstrapping subjects, accounting for potential correlations of kidneys within subjects.
Differences in agreement between readers will be based on comparing reader specific kappas, with statistical significance of these differences tested via bootstrapping.
An overall kappa will be computed for each paired imaging comparison by averaging kappas across readers, with a 95% interval calculated via bootstrapping.
Differences in overall kappas for the 3 paired imaging comparisons will be assessed using a bootstrap test.
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(Baseline, 4 months)
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Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Nervous System Diseases
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Congenital Abnormalities
- Renal Insufficiency
- Genetic Diseases, Inborn
- Abnormalities, Multiple
- Neurocutaneous Syndromes
- Ciliopathies
- Angiomatosis
- Kidney Neoplasms
- Kidney Diseases
- Renal Insufficiency, Chronic
- Von Hippel-Lindau Disease
Other Study ID Numbers
- LCCC1824
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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