Primary objective:-To diagnose acute pyelonefritis with MRI in comparison with the reference standard: DMSA scanning.Secondary objectives:- To determine whether MR-diffusion weighted imaging (DWI) has additional value in the imaging of…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pyelonephritis foci in renal parenchyma.
Secondary outcome
Renal scarring.
Background summary
Urinary tract infection (UTI) is a common and critical childhood disease which
occurs in at least 8 % of all girls and 2 % of all boys.
UTI may lead to upper tract infection and acute pyelonephritis if prompt
diagnosis and treatment are delayed. In later life this may then lead to
hypertension and impaired renal function. Therefore acute pyelonefritis needs
prompt diagnosis in order to start antibiotic therapy to prevent scar
formation.
Although children with pyelonephritis tend to present with fever, flank pain
and a positive urine culture, the diagnosis is usually difficult to make on
clinical grounds, especially in young children. Thus there is the need to
support or reject the diagnosis with radiological examination.
Currently the accepted reference standard for the diagnosis of acute
pyelonephritis is DMSA scanning. Unfortunately there are some disadvantages to
this technique. First of all, the need for an infusion needle and the exposure
to ionising radiation.
MRI has the potential to diagnose pyelonephritis surpassing these
disadvantages.
Study objective
Primary objective:
-To diagnose acute pyelonefritis with MRI in comparison with the reference
standard: DMSA scanning.
Secondary objectives:
- To determine whether MR-diffusion weighted imaging (DWI) has additional value
in the imaging of pyelonephritis.
- To determine whether MRI scanning can differentiate acute pyelonephritis from
renal scarring
Study design
Level IIb study, validating cohort.
Study burden and risks
Burden
- Patients need to lie stil, furthermore the MRI makes loud noises.
Wilhelminalaan 12
1815 JD Alkmaar
Nederland
Wilhelminalaan 12
1815 JD Alkmaar
Nederland
Listed location countries
Age
Inclusion criteria
1. Patients from 0 to 18 years with:
Acute pyelonephritis, defined as a UTI * with a body temperature above 38 °C.
Suspicion of acute pyelonephritis, suggested by symptoms of a UTI and flank pain.
2. Outside the study setting, the patient would have received a DMSA scan
3. Patients, or a legal representative, must be able to give informed consent, and the consent must be obtained prior to the MR Imaging and DMSA scanning
Exclusion criteria
1. Previous diagnosis of pyelonephritis
2. All contra-indications for undergoing MRI.
3. A psychiatric, addictive, or any disorder that compromises the ability to give truly informed consent for participation in this study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL32462.094.10 |