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NCT02371551

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

Completed Last updated 28 August 2019
What this trial tests

trial testing Blood/urine sampling in Cystic Renal Diseases in 52 participants. Completed in 30 June 2018.

Timeline
19 August 2014
Primary endpoint
20 October 2017
30 June 2018

Quick facts

Lead sponsorInsel Gruppe AG, University Hospital Bern
StatusCompleted
Study typeOBSERVATIONAL
Enrollment52
Start date19 August 2014
Primary completion20 October 2017
Estimated completion30 June 2018
Sites1 location across Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

Insel Gruppe AG, University Hospital Bern

Who can join

Adults 18 to 99, any sex, with Cystic Renal Diseases or Kidney Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Trials by the same sponsor.

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