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

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Brief Title

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

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

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)
    

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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

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

Condition

Von-Hippel Lindau

Intervention

Perflutren lipid microsphere

Study Arms / Comparison Groups

 Perflutren Lipid Microsphere or Lumason
Description:  Patients with Von-Hippel Lindau disease will be imaged using contrast-enhanced ultrasound with either perflutren or Lumason.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

15

Start Date

September 23, 2019

Completion Date

June 2022

Primary Completion Date

June 2022

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
      

Gender

All

Ages

16 Years - 99 Years

Accepts Healthy Volunteers

No

Contacts

Emily Chang, MD, 919-966-6957, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03907657

Organization ID

LCCC1824


Responsible Party

Sponsor

Study Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

 Lantheus Medical Imaging

Study Sponsor

Emily Chang, MD, Principal Investigator, University of North Carolina, Chapel Hill


Verification Date

June 2021