Clinical trial NCT04021238: Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging
Official title: Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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 β-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

Primary outcomes:
measure: 3D CEUS Generated Metrics in Kidney Mass: Wash_In_Slope
timeFrame: Baseline- up to 3 minutes
measure: 3D CEUS Generated Metric in Kidney Mass: Wash_In_intercept
timeFrame: Baseline- up to 3 minutes
measure: 3D CEUS Generated Metric in Kidney Mass: Wash_Out_Slope
timeFrame: Baseline- up to 3 minutes
measure: 3D CEUS Generated Metric in Kidney Mass: Wash_Out_Intercept
timeFrame: Baseline- up to 3 minutes
measure: 3D CEUS Generated Metric in Kidney Mass: FR_a
timeFrame: Baseline- up to 3 minutes
measure: 3D CEUS Generated Metric in Kidney Mass: FR_beta
timeFrame: Baseline- up to 3 minutes
measure: 3D CEUS Generated Metric in Kidney Mass: Volume
timeFrame: Baseline- up to 3 minutes
measure: 3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. Wash_In_Slope
timeFrame: Baseline- up to 3 minutes
measure: 3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. Wash_In_intercept
timeFrame: Baseline- up to 3 minutes
measure: 3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. Wash_Out_Slope
timeFrame: Baseline- up to 3 minutes
measure: 3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. Wash_Out_Intercept
timeFrame: Baseline- up to 3 minutes
measure: 3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. FR_a
timeFrame: Baseline- up to 3 minutes
measure: 3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. FR_beta
timeFrame: Baseline- up to 3 minutes
measure: 3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. Volume
timeFrame: Baseline- up to 3 minutes
Secondary outcomes:
measure: 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. Wash_In_Slope
timeFrame: Baseline- up to 3 minutes
measure: 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. Wash_In_intercept
timeFrame: Baseline- up to 3 minutes
measure: 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. Wash_Out_Slope
timeFrame: Baseline- up to 3 minutes
measure: 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. Wash_Out_Intercept
timeFrame: Baseline- up to 3 minutes
measure: 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. FR_a
timeFrame: Baseline- up to 3 minutes
measure: 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. FR_beta
timeFrame: Baseline- up to 3 minutes
measure: 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. Volume
timeFrame: Baseline- up to 3 minutes
measure: Pooled Kidney Mass Stage vs. 3D CEUS-generated Wash in Metrics
timeFrame: Baseline- up to 3 minutes
measure: Pooled Kidney Mass Stage Using 3D CEUS-generated Wash Out Metrics
timeFrame: Baseline- up to 3 minutes
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Emily Chang, MD
role: PRINCIPAL_INVESTIGATOR
References: