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

NCT02371551 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 52

Last updated 2019-08-28

No results posted yet for this study

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.

Conditions

  • Cystic Renal Diseases
  • Kidney Neoplasms

Interventions

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

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-19
Primary Completion
2017-10-20
Completion
2018-06-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02371551 on ClinicalTrials.gov