Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging

  • End date
    May 4, 2022
  • participants needed
  • sponsor
    UNC Lineberger Comprehensive Cancer Center
Updated on 4 February 2021


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)


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.

Condition urinary tract neoplasm, Malignant neoplasm of kidney, Nephropathy, Kidney Disease (Pediatric), Kidney Cancer, Kidney Disease, Renal Cancer, Urologic Cancer, cancer, renal
Treatment Perflutren Lipid microsphere, Sulfur Hexafluoride Lipid Microspheres
Clinical Study IdentifierNCT04021238
SponsorUNC Lineberger Comprehensive Cancer Center
Last Modified on4 February 2021


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Inclusion Criteria

Is your age between 18 yrs and 99 yrs?
Gender: Male or Female
Do you have any of these conditions: Kidney Cancer or Malignant neoplasm of kidney or Kidney Disease or urinary tract neoplasm or Renal Cancer or Urologic Cancer or Kidney Disease (Pediat...?
Do you have any of these conditions: urinary tract neoplasm or Kidney Cancer or Nephropathy or Renal Cancer or cancer, renal or Kidney Disease (Pediatric) or Kidney Disease or Malignant n...?
Do you have any of these conditions: cancer, renal or Renal Cancer or Malignant neoplasm of kidney or Kidney Disease or Kidney Disease (Pediatric) or Urologic Cancer or urinary tract neop...?
A suspected diagnosis of kidney cancer with a solid or partially solid lesion and planned surgical nephrectomy within 3 months before surgery
Able to provide informed consent
Willing to comply with protocol requirements
At least 18 years of age

Exclusion Criteria

Critically ill or medically unstable or in an intensive care setting and whose critical course during a potential 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
Has any other medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data or of achieving the study objectives
Unstable cardiopulmonary disease including any of the following
Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association)
Unstable angina
Symptomatic arrhythmia (i.e. tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia, atrial flutter or fibrillation)
Myocardial infarction within 14 days prior to the date of proposed microbubble administration
Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine -HCG results, obtained the same day as the CEUS, or on the basis of patient history, e.g.: tubal ligation, hysterectomy or a minimum of 1 year without menses)
Obesity that limits obtainment of acceptable images
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