Correlation of Renal Mass Pathologic Grade and Contrast Enhanced Ultrasound (CEUS)

Phase 4

Terminated

• Conditions: Renal Malignant Tumor
• Interventions: Drug: Contrast enhanced ultrasound with Lumason

• Registration Number: NCT03821376
• Lead Sponsor: Indiana University

Brief Summary

Patients with renal lesions suspicious for renal cell carcinoma (RCC) have a variety of different treatment pathways available to them. Imaging surveillance is being used frequently on smaller renal masses, and radiologists are being asked to biopsy more renal lesions to better guide decision making by urology. This is in large part due to the pathologic grade of renal masses having been shown to correlate with patient outcomes. The World Health Organization (WHO) or Fuhrman grade is the standard grading scale used by pathologists for RCC. The goal of this study will be to correlate contrast enhanced ultrasound findings with the pathologic grade of RCC. Specifically, the investigators hypothesize that tumors with different pathologic grades will show different patterns of qualitative enhancement, as well as different perfusion kinetics.

Detailed Description

Renal malignancies are relatively common, with lifetime risk ranging from 1 in 48 in men to 1 in 83 in women, of which RCC is the most common. RCC comes in a variety of subtypes, and pathologic grade has been shown to be one factor that correlates with patient prognosis \[Novara et al\]. The most commonly used pathologic grading systems are the WHO or Fuhrman scale, which rely on histologic features of the tumor such as nuclear size, irregularity, and nucleolar prominence.

Care of patients with RCC depends on a number of factors, including size and pathologic grade. As such, radiologic surveillance with CT and MRI is common, and percutaneous biopsy of renal masses for the purpose of pathologic grading is also relatively common. While percutaneous biopsy of renal masses is the least invasive way to obtain tissue, these still carry risks, especially of hemorrhage give the vascular nature of the kidneys and RCC.

Contrast enhanced ultrasound has been shown to have the ability to differentiate renal masses from normal background renal parenchyma \[Barr et al\]. It has the unique ability to be used in patients with renal dysfunction as it is excreted by the liver and lungs. As such, it is well suited for use in patients with underlying renal pathology. This study will aim to use contrast enhanced ultrasound to evaluate the qualitative and quantitative features of renal masses prior to surgical removal, and then evaluate for correlation of these features with pathologic grading following surgery.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-01-28
• Study First Posted: 2019-01-29
• Study Start: 2019-07-16
• Primary Completion: 2021-09-21
• Study Completion: 2021-09-21
• Results First Submitted: 2024-07-22
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-09
• Last Update Submitted: 2024-10-09
• Results First Posted: 2024-10-10
• Last Update Posted: 2024-10-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Greater than or equal to 18 years of age
• Previously identified renal mass with radiology and clinical features consistent with RCC
• Clinical care plan includes partial or total nephrectomy

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Exclusion Criteria

• Less than 18 years of age
• Currently pregnant
• Renal mass with clinical care plan that does not include nephrectomy
• Renal mass suspected to be non RCC neoplasm by imaging and clinical data
• Renal mass unable to be visualized by grayscale ultrasound
• Known renal vein thrombosis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Renal malignancy	Contrast enhanced ultrasound with Lumason	Patients with renal mass(es) identified by cross sectional imaging, specifically ultrasound following the intravenous injection of Lumason

Primary Outcome Measures

Name	Time	Method
Contrast Enhanced Ultrasound Features of Renal Masses (Time to Peak, Mean Transit Time)	6 months	Ultrasound images will be reviewed for quantitative post contrast features (time to peak, mean transit time)
Contrast Enhanced Ultrasound Features of Renal Masses (Peak Intensity)	6 months	Ultrasound images will be reviewed for quantitative post contrast features. Specifically peak intensity, which is measured in "enhancement units." A higher value represents more blood flow to the renal mass.

Trial Locations

Locations (1)

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States