Contrast Ultrasound Dispersion Imaging (CUDI) as a Diagnostic Modality in the Diagnosis of Renal Cell Carcinoma (CUDI-RCC)

December 9, 2020 updated by: Prof.dr. H.P. Beerlage, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Introduction The current limitations of renal cell carcinoma (RCC) imaging form a major deficit in the diagnostic pathway. Contrast Enhanced UltraSound (CEUS) has the potential to improve RCC detection and localization significantly. CEUS image interpretation is however difficult and subjective. To overcome these difficulties a CEUS quantification technique, Contrast-enhanced Ultrasound Dispersion Imaging (CUDI), has been developed in cooperation with the Eindhoven University of Technology (TU/e).

Study objective Primary objective: To assess the sensitivity and specificity of CUDI for recognizing malignant tissue in vivo.

Study population All patients scheduled for a partial or radial nephrectomy in the Amsterdam UMC (Amsterdam Universitair Medische Centra) Study Procedure This study is a prospective in-vivo study in patients scheduled for a partial or radical nephrectomy for a suspicious RCC in which we will perform CEUS imaging. The (partial) nephrectomy is part of standard care for patients with a suspicious lesion in the kidney. The additional ultrasound with infusion of an ultrasound contrast agent during ultrasound scanning is performed for the purpose of the study. CEUS imaging will be performed right before (partial) nephrectomy, with the patient being under general anesthesia. The CEUS and CUDI parametric maps will be interpreted by Investigator A in a blinded fashion with suspicious lesions each delineated. The (partial) nephrectomy will be performed by a qualified urologist, and the analysis of the histological specimens will be performed by a qualified pathologist. Sensitivity and specificity for CUDI will be calculated for all patients receiving a (partial) nephrectomy in which the tissue is sent for pathology.

Benefits Currently, most renal tumors are diagnosed by abdominal US, CT or MRI. Renal tumors are classified as cystic or solid lesions on imaging. The most important criteria for differentiating malignant lesions is the presence of enhancement after administration of contrast for CT or MRI in several different phases (4 phases CT-scan). Enhancement in renal masses is determined by comparing Hounsfield units before and after administration of contrast. A change of 15 or more Hounsfield units demonstrates enhancement. Specificity and sensitivity for detecting RCC are around 75% and 88% for CT, and around 89% and 87.5% for MRI, respectively.

Both CT and MRI can objectify a contrast-enhancing mass, suspicious for RCC, however, they cannot reliably distinguish a benign lesion (such as an oncocytoma or angiomyolipoma) from a malignant renal neoplasm. For that reason, patients are currently undergoing an RTB (renal tumor biopsy) to objectify pathology for deciding if treatment is necessary or not. Recent literature suggests up to 30% benign pathology after partial nephrectomy implicating overtreatment. RTB has been gradually introduced and increasingly used, however, an RTB is not without risks. Bleeding is the most documented complication. Recently even tumor tract seeding has been under discussion. Improving imaging by using CUDI for differentiating benign from malignant lesions instead of performing an RTB could prevent those risks for patients.

Risk assessment There is a small risk of contrast-related adverse events (AE) for participants. After use in millions of patients, AE to the ultrasound contrast agent appear to be transient, mild and rare, and mostly consist of transient alteration of taste, local pain at the injection site and facial or general flush. In some cases, a mild allergic reaction is described. Patients will be informed of the risk during contrast exposure, and it will be described in the patient information file.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105AZ
        • Amsterdam UMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age ≥ 18 years
  • signed informed consent
  • scheduled for a radical- or partial nephrectomy for the suspicious of a renal tumor.

Exclusion Criteria:

  • Earlier treatment of renal masses
  • History of any clinically evidence of cardiac right-to-left shunts
  • Severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
  • Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study
  • Is incapable of understanding the language in which the information for the patient is given
  • Tumor cannot be visualized/localized on ultrasound imaging
  • Previous hypersensitivity allergic reactions
  • Known allergy of macrogol 4000, distearoylphosphatidylcholine, dipalmitoylphosphatidylglycerol Sodium, Palmitic acid
  • Use of dobutamine or conditions suggesting cardiovascular instability where dobutamine is contraindicated.
  • Pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients
Other: CUDI
Analysis of the CEUS data by means of Contrast ultrasound dispersion imaging
Other Names:
  • Contrast ultrasound dispersion imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
per-patient RCC detection rates
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Rate of malignant histology that can be correlated to CUDI-parameters
Time Frame: through study completion, an average of 1 year
After receiving both the CUDI-data and the histology data, both will be compared to check if the regions that show different CUDI-parameters match the regions with malignancy in histology
through study completion, an average of 1 year
Wash out time as a parameter to measure the dispersion of the micro bubbles of the CUDI contrast agent
Time Frame: through study completion, an average of 1 year
This is a physical parameter that is quantified from CEUS-data by CUDI. The wash out time is the time that it takes for the micro bubbles to disappear.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
sensitivity of CUDI
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
specificity of CUDI
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
negative predictive value of CUDI
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
positive predictive value of CUDI
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 30, 2020

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

July 21, 2020

First Submitted That Met QC Criteria

December 9, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 9, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUDI-RCC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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