|- candidate number||12334|
|- NTR Number||NTR3422|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-mei-2012|
|- Secondary IDs||NL39734.078.12 CCMO|
|- Public Title||Studie naar een nieuwe methode om vast te kunnen stellen of een niercyste goed- of kwaadaardig is.|
|- Scientific Title||Validation of a strategy to identify benign pathology in patients operated for a complex renal cyst.|
|- Healt Condition(s) or Problem(s) studied||Renal cysts|
|- 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||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;
10. Renal insufficiency (Glomerular Filtration Rate (GFR) < 30 ml/min).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-jun-2012|
|- planned closingdate||1-jun-2015|
|- Target number of participants||80|
|- Interventions||Diagnostic panel:|
1. Contrast Enhanced UltraSound (CEUS);
2. Magnetic Resonance Imaging (MRI) with contrast;
3. Fine Needle Aspiration (FNA).
|- Primary outcome||Sensitivity of the diagnostic panel.|
|- Secondary outcome||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.
|- Timepoints||Maximal 4 visits in 15 weeks.|
|- Trial web site||www.erasmusmc.nl/urotrials|
|- CONTACT FOR PUBLIC QUERIES||Dr. P.C.M.S. Verhagen|
|- CONTACT for SCIENTIFIC QUERIES||Dr. P.C.M.S. Verhagen|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Urology|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, Department of Urology|
|- Brief summary||Background of the study:|
As a result of the widespread and increasing use of abdominal imaging, the incidence of small renal masses, including
renal cysts is increasing. Based on contrast enhanced CT scan, lesions can be classified as simple or complex. Approximately 50% of these complex cysts prove to be benign on resection. It is currently not possible to differentiate benign from malignant disease before surgery. Therefore, the standard of care is to advise patients to undergo a partial nephrectomy. Cohort studies show that 5-10% of patients experience major urological complications.
Objective of the study:
To validate a diagnostic panel existing of MRI, CEUS, and FNA, which can differentiate benign pathology from malignant pathology of complex renal cysts.
Prospective, observational, cohort study.
Patients with a complex renal cyst on a contrast enhanced CT scan are included in this trial.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
There are a couple of risks associated with the use of contrast agent for ultrasonography and MRI. Patients with a
known allergy to contrast agents are therefore excluded from participation in the trial (see also the exclusion criteria).
Known side effects of the use of contrast agents are: Serious allergic reactions, headache, reaction on the site of
injection (bruise, redness, numb feeling), pain at the injection site, hypersensitive reaction (e.g. abnormal redness of
the skin, slow heart beat, low blood pressure, or, rarely, anaphylactic shock).
Countries of recruitment:
|- Main changes (audit trail)|
|- RECORD||4-mei-2012 - 9-sep-2013|