Evaluation of Complex Renal Cyst With CEUS/Functional MRI Versus CT

August 27, 2019 updated by: University Hospital Inselspital, Berne

Evaluation of Complex Renal Cystic Lesions With Contrast Enhanced Ultrasound (CEUS) and Functional MRI Versus the Gold Standard: Computer Tomography (CT)

The primary concern in complex renal cysts (CRC) with malignant potential is the accurate diagnosis and characterization. Patients with CRC have to undergo frequent imaging surveillance (every 6-12 Mo), in which the progression suggests a neoplastic process. The gold standard for establishing diagnosis and necessity for surgical intervention (i.e. partial nephrectomy) is conventional computer tomography (CT) imaging. Its main drawback is the radiation dose to the body and intravenous contrast media administration, which has a risk of nephrotoxicity.

Magnetic resonance imaging (MRI) with special functional sequences (fMRI) and contrast-enhanced ultrasonography (CEUS) allow measuring tissue blood flow and perfusion characteristics without ionizing radiation or nephrotoxic contrast media. To compare the diagnostic accuracy, sensitivity and specificity of CEUS/functional MRI versus the gold standard CT, 60 patients with CRC will be evaluated using all these 3 modalities. The main hypothesis is that fMRI and CEUS have equal accuracy with CT regarding diagnosis and classification of CRC lesions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background

Renal cysts occur in a variety of diseases but also in normal kidneys (i.e. simple cysts). Diagnostic imaging plays a central role in the diagnosis of renal cysts and lesions. Most patients are diagnosed after undergoing imaging (computed tomography [CT], magnetic resonance imaging [MRI], ultrasound [US]) for an unrelated reason and their increasing incidental finding during the last decade parallels the growing use of imaging procedures.

Simple renal cysts are commonly observed in normal kidneys and are of limited clinical relevance. The primary clinical concern is the accurate evaluation of complex renal cysts (CRC) that have a malignant potential. Based upon the initial radiographic evaluation, further studies may be required, and some complex lesions may require surgical excision for exact diagnosis, based on growth during follow up.

The gold standard for the diagnosis of CRC is conventional CT imaging. Its main drawback is the radiation dose to the body and intravenous contrast media administration, which has a risk of nephrotoxicity. In order to accurate classify and manage these lesions, the Bosniak renal cyst classification system was created. Based upon morphologic and enhancement characteristics of the CT scan, cystic renal masses are placed in one of five categories (I, II, IIF, III, IV).

Although not yet validated for reader agreement or generalizability, the Bosniak renal cyst classification system has been widely accepted by urologists and radiologists as the best way to assess and follow these CRC lesions. While the Bosniak classification is based on CT findings, the same approach is applicable as a useful predefined framework for the evaluation of CRC with other radiographic modalities i.e. with MRI and conventional or contrast-enhanced ultrasound. The ability to differentiate between those that are benign versus malignant (surgical versus nonsurgical masses) still represents a major challenge.

Magnetic resonance imaging (MRI) has gained immense popularity over the last decades as it allows generation of very high-resolution images, including 3D reconstructions, without ionizing radiation. Functional MRI can be performed with or without injection of contrast, thus avoiding the risk of nephrogenic systemic sclerosis in patients with chronic kidney disease (CKD). Diffusion weighted imaging (DW-MRI), blood-oxygen-level-dependent (BOLD) MRI and arterial spin labeling (ASL) sequences are functional sequences which can be performed without injection of contrast.

The recent development and availability of a contrast-enhanced ultrasonography (CEUS) using microbubbles has further improved sensitivity and diagnostic confidence with respect to conventional and colour-Doppler US. They allow vascular bed opacification and have opened the way to detecting the microcirculation. CEUS was able to detect changes in human renal cortical microcirculation. Thus it seems to be a feasible technique to evaluate (i.e. perfusion pattern of the cyst wall or perfusion of the septa) CRC using the Bosniak classification system.

Ideally, the method for the evaluation of CRC should be safe, non-invasive, and accurate. Abdominal CT scanning delivers significant ionizing radiation, which may be a consideration for younger patients (age <35 years), utilizes contrast media with a considerable nephrotoxicity and risk of an allergic reaction. No prospective study comparing CT with CEUS or functional MRI for the evaluation of CRC has been conducted.

Objective

The primary aim of this study is to evaluate the diagnostic accuracy, sensitivity and specificity of CEUS/fMRI and compare it with abdominal CT the current gold standard diagnostic modality.

Methods

Prospective, single center, observational setting. Patients with CRC who fulfill the inclusion criteria will be further evaluated after written informed consent. Kidney function and the CRC progression will be followed according to the current medical standards. If a significant change in cystic lesions is observed, further evaluation and surgical intervention, if indicated, will be initiated by the primary physician in charge. Testing will be performed upon study entry and after 12 months according to the following schedule:

  • Blood-sampling
  • CT
  • fMRI
  • renal CEUS
  • chart review Two study physicians independently will review the CEUS and functional MRI images of the patients. The reviewers will be aware of study design but will be blinded to the clinical information of the CT findings. The scoring system for image interpretation will be based on the Bosniak cyst classification.

Study Type

Observational

Enrollment (Actual)

52

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

  • Switzerland
      • Bern, Switzerland, CH-3010
        • Dep. of Nephrology, Hypertension and Clinical Pharmacology, Bern University Hospital

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 to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who were referred to the outpatient clinic of the Department of Nephrology or to the Department of Urology, Bern University Hospital for the clarification of a complex renal cyst/lesion and already underwent or will undergo a standard CT examination or patient who where accidentally diagnosed with a complicated renal cyst/lesion from the Department of Nephrology, Urology or Radiology (with CT imaging)

Description

Inclusion Criteria:

  • Age > 18 years old
  • Written informed consent
  • A complicated renal cyst (Bosniak category > II cyst or hemorrhagic cyst) or lesion > 1 cm im max. transverse diameter who will undergo standard renal CT imaging
  • Stable renal function (GFR> 30 ml/min/1.73 m2)

Exclusion Criteria

  • Pregnancy
  • History of allergic reaction to contrast agents
  • Refusal to adhere to follow-up
  • Recent pyelonephritis
  • Acute kidney injury (AKI stage ≥ 1)
  • Other individuals especially in need of protection (according to the Swiss Academy of Medical Sciences)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
All patients
Other: Blood/urine sampling
Routine chemistry profile
Other: Conventional routine CT examination
Standard diagnostic examination
Other: Contrast-enhanced renal ultrasonography (CEUS)
Study-specific diagnostic examination
Other: Functional MRI
Study-specific diagnostic examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CRC classification according to CT-finding based on Bosniak criteria or until surgical intervention
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Diagnostic accuracy of CEUS and fMRI based on the progression of CRC according to CT-finding and Bosniak classification throughout visit 1-2
Time Frame: 1 year
1 year
Diagnostic accuracy of CEUS and fMRI based on surgical extraction and histopathological evaluation of the resected mass
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Spyridon Arampatzis, MD, Dep. of Nephrology, Hypertension and Clinical Pharmacology, Bern University Hospital

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 (ACTUAL)

August 19, 2014

Primary Completion (ACTUAL)

October 20, 2017

Study Completion (ACTUAL)

June 30, 2018

Study Registration Dates

First Submitted

February 19, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (ESTIMATE)

February 25, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 84/14

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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