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

NCT ID: NCT03821376

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-16
• Study Completion Date: 2021-09-21

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.

Conditions

Renal Malignant Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Renal malignancy

Patients with renal mass(es) identified by cross sectional imaging, specifically ultrasound following the intravenous injection of Lumason

Group Type: EXPERIMENTAL

Contrast enhanced ultrasound with Lumason

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Ultrasound

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Jordan K. Swensson

Assistant Professor of Clinical Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jordan Swennson, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University Hospital

Indianapolis, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1901057253

Identifier Type: -

Identifier Source: org_study_id