Clinical trial · Observational
Evaluation of Complex Renal Cyst With CEUS/Functional MRI Versus CT
Evaluation of Complex Renal Cystic Lesions With Contrast Enhanced Ultrasound (CEUS) and Functional MRI Versus the Gold Standard: Computer Tomography (CT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cystic Renal Diseases | — | UNRESOLVED | — |
| Kidney Neoplasms | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood/urine sampling | Other | — | UNRESOLVED |
| Contrast-enhanced renal ultrasonography (CEUS) | Other | — | UNRESOLVED |
| Conventional routine CT examination | Other | — | UNRESOLVED |
| Functional MRI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- All patients
- interventionNames
- Other: Blood/urine sampling
- Other: Conventional routine CT examination
- Other: Contrast-enhanced renal ultrasonography (CEUS)
- Other: Functional MRI
Primary outcomes (1)
- measure
- CRC classification according to CT-finding based on Bosniak criteria or until surgical intervention
- timeFrame
- 1 year
Secondary outcomes (2)
- measure
- Diagnostic accuracy of CEUS and fMRI based on the progression of CRC according to CT-finding and Bosniak classification throughout visit 1-2
- timeFrame
- 1 year
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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)
References
Publications (5)
- BACKGROUNDBosniak MA. Diagnosis and management of patients with complicated cystic lesions of the kidney. AJR Am J Roentgenol. 1997 Sep;169(3):819-21. doi: 10.2214/ajr.169.3.9275903. No abstract available. PMID 9275903
- BACKGROUNDCurry NS, Cochran ST, Bissada NK. Cystic renal masses: accurate Bosniak classification requires adequate renal CT. AJR Am J Roentgenol. 2000 Aug;175(2):339-42. doi: 10.2214/ajr.175.2.1750339. PMID 10915671
- BACKGROUNDBalci NC, Semelka RC, Patt RH, Dubois D, Freeman JA, Gomez-Caminero A, Woosley JT. Complex renal cysts: findings on MR imaging. AJR Am J Roentgenol. 1999 Jun;172(6):1495-500. doi: 10.2214/ajr.172.6.10350279. PMID 10350279
- BACKGROUNDNicolau C, Bunesch L, Sebastia C. Renal complex cysts in adults: contrast-enhanced ultrasound. Abdom Imaging. 2011 Dec;36(6):742-52. doi: 10.1007/s00261-011-9727-8. PMID 21461960
- BACKGROUNDSchneider AG, Hofmann L, Wuerzner G, Glatz N, Maillard M, Meuwly JY, Eggimann P, Burnier M, Vogt B. Renal perfusion evaluation with contrast-enhanced ultrasonography. Nephrol Dial Transplant. 2012 Feb;27(2):674-81. doi: 10.1093/ndt/gfr345. Epub 2011 Jun 20. PMID 21690200