To validate a diagnostic panel existing of MRI, CEUS, and FNA, which can differentiate benign pathology from malignant pathology of complex renal cysts.
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sensitivity of the diagnostic panel.
Secondary outcome
o Specificity of the diagnostic panel.
o Sensitivity and specificity of the MRI-test.
o Sensitivity and specificity of the CEUS-test.
o Sensitivity and specificity of the FNA-test.
o Sensitivity and specificity of the combination of the MRI-test and the
CEUS-test.
o Sensitivity and specificity of the combination of the MRI-test and the
FNA-test.
o Sensitivity and specificity of the combination of the CEUS-test and the
FNA-test.
o Positive predictive value of the MRI-test.
o Positive predictive value of the CEUS-test.
o Positive predictive value of the FNA-test.
o Positive predictive value of the combination of the MRI-test and the
CEUS-test.
o Positive predictive value of the combination of the MRI-test and the FNA-test.
o Positive predictive value of the combination of the CEUS-test and the
FNA-test.
o Proportion of patients with a complication of the diagnostic panel
o Number of upgraded lesions that are Bosniak IIF on CT.
Background summary
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.
Study objective
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 burden and risks
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).
's-Gravendijkwal 230
3015 CE Rotterdam
NL
's-Gravendijkwal 230
3015 CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
• Bosniak IIF, III, or IV renal cyst on contrast enhanced CT scan.
• Fit for surgery.
• Signed informed consent.
• Age >= 18 years.
Exclusion criteria
• Pregnancy or breastfeeding.
• Women unwilling to use an effective birth control method during study participation.
• Known allergy to contrast agents or sulphur hexafluoride micro bubbles.
• Any clinically unstable cardiac condition within 7 days prior to contrast agent administration such as:
o evolving or ongoing myocardial infarction.
o typical angina at rest.
o significant worsening of cardiac symptoms.
o recent coronary artery intervention or other factors suggesting clinical.
o instability (e.g., recent deterioration of Electrocardiogram (ECG), laboratory or clinical findings).
o acute cardiac failure, class III/IV cardiac failure.
o severe cardiac rhythm disorders.
o right-to-left shunts.
• Severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome.
• Severe cardiac condition.
• Vulnerable for convulsions.
• Presence of a pacemaker or other implants or clamps or other contra-indication for MRI.
• Claustrophobia
• Renal insufficiency (Glomerular Filtration Rate (GFR) < 30 ml/min).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL39734.078.12 |
| OMON | NL-OMON28890 |