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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02371551
Recruitment Status : Completed
First Posted : February 25, 2015
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:

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.


Condition or disease Intervention/treatment
Cystic Renal Diseases Kidney Neoplasms Other: Blood/urine sampling Other: Conventional routine CT examination Other: Contrast-enhanced renal ultrasonography (CEUS) Other: Functional MRI

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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Complex Renal Cystic Lesions With Contrast Enhanced Ultrasound (CEUS) and Functional MRI Versus the Gold Standard: Computer Tomography (CT)
Actual Study Start Date : August 19, 2014
Actual Primary Completion Date : October 20, 2017
Actual Study Completion Date : June 30, 2018

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




Primary Outcome Measures :
  1. CRC classification according to CT-finding based on Bosniak criteria or until surgical intervention [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]
  2. Diagnostic accuracy of CEUS and fMRI based on surgical extraction and histopathological evaluation of the resected mass [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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)

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): NCT02371551


Locations
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Switzerland
Dep. of Nephrology, Hypertension and Clinical Pharmacology, Bern University Hospital
Bern, Switzerland, CH-3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Spyridon Arampatzis, MD Dep. of Nephrology, Hypertension and Clinical Pharmacology, Bern University Hospital

Publications:
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02371551    
Other Study ID Numbers: 84/14
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Keywords provided by University Hospital Inselspital, Berne:
Diffusion Magnetic Resonance Imaging
Medical Sonography
Computed Tomography, X-Ray
Additional relevant MeSH terms:
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Kidney Neoplasms
Kidney Diseases, Cystic
Kidney Diseases
Urologic Diseases
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms