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

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ClinicalTrials.gov Identifier: NCT03907657
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
Lantheus Medical Imaging
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

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)

Condition or disease Intervention/treatment Phase
Von-Hippel Lindau Kidney Disease, Chronic Drug: Perflutren lipid microsphere Drug: Sulfur hexafluoride lipid microspheres Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020


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.
Drug: 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.
Other Names:
  • • Definity®
  • • Microbubble contrast agent

Drug: 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.
Other Name: Lumason




Primary Outcome Measures :
  1. Change in Radiologist's Lesion Evaluation compared to B-mode Ultrasound (percent) [ Time Frame: (Baseline) ]
    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.


Secondary Outcome Measures :
  1. Change in Radiologist's Lesion Evaluation compared to contrasted MRI (percent) [ Time Frame: (Baseline, 4 months) ]
    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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Ages Eligible for Study:   16 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03907657


Contacts
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Contact: Shanah Kirk 919-966-6957 shanah_kirk@med.unc.edu
Contact: Desma Jones, BS,CCRC 919-843-9463 desma_jones@med.unc.edu

Locations
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United States, North Carolina
University of North Carolina of Chapel hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7510
Contact: Shanah Kirk    919-966-6957    shanah_kirk@med.unc.edu   
Contact: Desma Jones, BS,CCRC    919-843-9463    desma_jones@med.unc.edu   
Principal Investigator: Emily Chang, M.D.         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Lantheus Medical Imaging
Investigators
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Principal Investigator: Emily Chang, MD University of North Carolina, Chapel Hill

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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03907657     History of Changes
Other Study ID Numbers: LCCC1824
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Neoplasms
Von Hippel-Lindau Disease
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Neurocutaneous Syndromes
Nervous System Diseases
Angiomatosis
Vascular Diseases
Cardiovascular Diseases
Ciliopathies
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Renal Insufficiency