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Correlation of Renal Mass Pathologic Grade and CEUS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821376
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Jordan K. Swensson, 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 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.

Condition or disease Intervention/treatment Phase
Renal Malignant Tumor Drug: Contrast enhanced ultrasound with Lumason Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention 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
Primary Purpose: Diagnostic
Official Title: Correlation of Contrast Enhanced Ultrasound of Renal Masses With Pathologic Grade: A Prospective Comparison of Quantitative and Qualitative Findings
Actual Study Start Date : July 16, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Renal malignancy
Patients with renal mass(es) identified by cross sectional imaging, specifically ultrasound following the intravenous injection of Lumason
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).
Other Name: Ultrasound




Primary Outcome Measures :
  1. Correlation of contrast enhanced ultrasound features of renal masses with pathologic grade [ Time Frame: first 6 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821376


Contacts
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Contact: Jordan Swensson, MD 317-944-1837 jswensso@iu.edu
Contact: SaraH Munson, RN 317-963-0305 sed@iu.edu

Locations
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United States, Indiana
Indiana University Hospital Recruiting
Indianapolis, Indiana, United States, 46022
Contact: Sarah Munson    317-963-0305    sed@iu.edu   
Sponsors and Collaborators
Indiana University

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Responsible Party: Jordan K. Swensson, Assistant Professor of Clinical Radiology, Indiana University
ClinicalTrials.gov Identifier: NCT03821376    
Other Study ID Numbers: 1901057253
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases