Niercysten, renale cysten (kidney cysts, renal cysts)
Conditions
Interventions
Diagnostic panel:
1. Contrast Enhanced UltraSound (CEUS)
2. Magnetic Resonance Imaging (MRI) with contrast
3. Fine Needle Aspiration (FNA).
Sponsors
Erasmus MC (Dept. Urology)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Bosniak IIF, III, or IV renal cyst on contrast enhanced CT scan; 2. Fit for surgery; 3. Signed informed consent; 4. Age ≥ 18 years.
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breastfeeding; 2. Women unwilling to use an effective birth control method during study participation; 3. Known allergy to contrast agents or sulphur hexafluoride micro bubbles; 4. Any clinically unstable cardiac condition within 7 days prior to contrast agent administration such as: A. Evolving or ongoing myocardial infarction; B. Typical angina at rest; C. Significant worsening of cardiac symptoms; D. Recent coronary artery intervention or other factors suggesting clinical; E. Instability (e.g., recent deterioration of Electrocardiogram (ECG), laboratory or clinical findings); F. Acute cardiac failure, class III/IV cardiac failure; G. Severe cardiac rhythm disorders; H. Right-to-left shunts. 5. Severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome; 6. Severe cardiac condition; 7. Vulnerable for convulsions; 8. Presence of a pacemaker or other implants or clamps or other contra-indication for MRI; 9. Claustrophobia; 10. Renal insufficiency (Glomerular Filtration Rate (GFR) < 30 ml/min).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity of the diagnostic panel. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Specificity of the diagnostic panel; 2. Sensitivity and specificity of the MRI-test; 3. Sensitivity and specificity of the CEUS-test; 4. Sensitivity and specificity of the FNA-test; 5. Sensitivity and specificity of the combination of the MRI-test and the CEUS-test; 6. Sensitivity and specificity of the combination of the MRI-test and the FNA-test; 7. Sensitivity and specificity of the combination of the CEUS-test and the FNA-test; 8. Positive predictive value of the MRI-test; 9. Positive predictive value of the CEUS-test; 10. Positive predictive value of the FNA-test; 11. Positive predictive value of the combination of the MRI-test and the CEUS-test; 12. Positive predictive value of the combination of the MRI-test and the FNA-test; 13. Positive predictive value of the combination of the CEUS-test and the FNA-test; 14. Proportion of patients with a complication of the diagnostic panel; 15. Number of upgraded lesions that are Bosniak IIF on CT. | — |
Contacts
Public ContactP.C.M.S. Verhagen
Dept. Urology Erasmus MC 's-Gravendijkwal 230
Outcome results
None listed