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

Primary Purpose

Renal Malignant Tumor

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Contrast enhanced ultrasound with Lumason
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Renal Malignant Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Indiana University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Renal malignancy

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 25, 2019
Last Updated
July 14, 2023
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT03821376
Brief Title
Correlation of Renal Mass Pathologic Grade and Contrast Enhanced Ultrasound (CEUS)
Official Title
Correlation of Contrast Enhanced Ultrasound of Renal Masses With Pathologic Grade: A Prospective Comparison of Quantitative and Qualitative Findings
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 16, 2019 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Malignant Tumor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Imaging findings for enrolled patients will be compared to pathologic grading
Masking
None (Open Label)
Masking Description
Imaging reviewers will be blinded to pathologic grade
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Renal malignancy
Arm Type
Experimental
Arm Description
Patients with renal mass(es) identified by cross sectional imaging, specifically ultrasound following the intravenous injection of Lumason
Intervention Type
Drug
Intervention Name(s)
Contrast enhanced ultrasound with Lumason
Other Intervention Name(s)
Ultrasound
Intervention Description
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).
Primary Outcome Measure Information:
Title
Correlation of contrast enhanced ultrasound features of renal masses with pathologic grade
Description
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.
Time Frame
first 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jordan Swensson, MD
Phone
317-944-1837
Email
jswensso@iu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Marissa Agoston, B.S.
Phone
317-963-4762
Email
magoston@iu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan Swennson, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46022
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marissa Agoston
Phone
317-963-4762
Email
magoston@iu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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