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

NCT03821376 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 1901057253
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Malignant Tumor

Outcome Measures

Primary Outcomes (2)

• Contrast Enhanced Ultrasound Features of Renal Masses (Time to Peak, Mean Transit Time)

  Ultrasound images will be reviewed for quantitative post contrast features (time to peak, mean transit time)

  6 months

• Contrast Enhanced Ultrasound Features of Renal Masses (Peak Intensity)

  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.

  6 months

Study Arms (1)

Renal malignancy

EXPERIMENTAL

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

Drug: Contrast enhanced ultrasound with Lumason

Interventions

Contrast enhanced ultrasound with Lumason 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).

Also known as: Ultrasound

Renal malignancy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46022, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Results Point of Contact

• Title: Jordan Swensson, MD
• Organization: Indiana University

jswensso@iu.edu

317-944-1831

Study Officials

• Jordan Swennson, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: Imaging reviewers will be blinded to pathologic grade
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Radiology

Model Details: Imaging findings for enrolled patients will be compared to pathologic grading

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: January 29, 2019
• Study Start: July 16, 2019
• Primary Completion: September 21, 2021
• Study Completion: September 21, 2021
• Last Updated: October 10, 2024
• Results First Posted: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)