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

Renal Malignant Tumor Clinical Trial

Official title:

Correlation of Contrast Enhanced Ultrasound of Renal Masses With Pathologic Grade: A Prospective Comparison of Quantitative and Qualitative Findings

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03821376
• Other study ID #: 1901057253
• Status: Recruiting
• Phase: Phase 4
• Start date: July 16, 2019
• Est. completion date: July 1, 2025

Study information

• Verified date: July 2023
• Source: Indiana University
• Contact: Jordan Swensson, MD
• Phone: 317-944-1837
• Email: jswensso[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Malignant Tumor

Intervention

Drug:
• Contrast enhanced ultrasound with Lumason
Following consent, they will undergo contrast enhanced ultrasound of their known renal mass(es). This will be performed at University hospital following intravenous administration of Lumason (2.5 mL per injection, maximum of 2 injections per mass).

Locations

Country	Name	City	State
United States	Indiana University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of contrast enhanced ultrasound features of renal masses with pathologic grade	Ultrasound images will be reviewed for qualitative imaging features as well as quantitative post contrast features (time to peak, area under the curve, mean transit time etc). These findings will then be correlated with the pathologic grade of surgically removed renal masses, to evaluate for differences in imaging features among the different pathologic grades.	first 6 months