Studie naar een nieuwe methode om vast te kunnen stellen of een niercyste goed- of kwaadaardig is.

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.



Study design:

Prospective, observational, cohort study.



Study population:

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:

The Netherlands.

N/A

Maximal 4 visits in 15 weeks.

Diagnostic panel:

1. Contrast Enhanced UltraSound (CEUS);

2. Magnetic Resonance Imaging (MRI) with contrast;

3. Fine Needle Aspiration (FNA).