Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if contrast-enhanced ultrasound can detect abnormal
      features of kidney lesions in patients with suspected kidney cancer 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. Eligible patients will include anyone who has
      suspected kidney cancer and is scheduled for surgery, up to an anticipated total of 40
      participants. 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.
    

Intervention name(s): Perflutren lipid microsphere; Sulfur hexafluoride lipid microspheres
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): Definity; Microbubble contrast agent; Lumason
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic