The Validity of the Quick Renal MRI in Pediatric Kidney Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-21
SponsorUniversity of Wisconsin, Madison
About this trial
The investigators propose a new imaging method for children born with congenital anomalies of the urinary tract that is a rapid, injection-, sedation-, and radiation-free alternative: the quick renal MRI. This proposal hypothesizes that the quick renal MRI has high validity compared to current radiologic standard for renal infection and scarring, the 99mTechnetium-dimercaptosuccinic acid (99mTc- DMSA) renal scan in the detection of acute renal infections and scars. If the quick renal MRI is accurate, it could potentially replace the DMSA scan for those specific questions and ease the burden of testing for children with chronic renal disease. Findings from these studies will provide preliminary data and rationale for a multi-centered study to further test this new technology.
Participants will be 0-21 years of age and can expect to be on study for from 1 week (if enrolled in Aim 1) to 6 months (if enrolled in Aim 2).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient is admitted to American Family Children's Hospital for a febrile UTI, suspected pyelonephritis, or diagnosed pyelonephritis
Undergoing clinical DMSA scan
Undergoing DMSA scans as a part of their routine clinical care
History of more than one UTI in the past year
Disqualifiers
No evidence of pyuria on their urine analysis
Negative urine culture
Not comfortable with having a Quick MRI performed
Contraindications to MRI
Trial design
Design model
Single group
Treatments tested in this trial
Quick MRI
Diagnostic testA quick MRI scan takes about 15 mins or less. No IV or sedation will be necessary. The participant will be required to lie flat and still during the test. A parent will be allowed to be with the participant while they are in the scanner. The machine will produce loud intermittent sounds of banging or knocking so they will have to wear protective headphones. They can listen to music if they would like. If they are less than 1 year old, they will be swaddled and can be "held" during the test. If a child needs to have a parent in the scanner, it is ideal if the parent can have their head near the participant's legs and arms stretched out to hold the child's hands. If the parent needs to be by the patient's head, it can be accomplished by the parent lying head to head with the child or the parent lying on the child. Ideally they are lying head to head, or just outside of the scanner reaching in.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: DMSA/Quick MRIOther 1 intervention
Trial outcomes
Primary outcomes
1
Sensitivity of Quick MRI as Compared to DMSA scan in Diagnosis of Suspected Acute Pyelonephritis
Children admitted for suspected acute pyelonephritis will undergo a clinical DMSA (gold-standard) renal scan and quick renal MRI to determine the sensitivity of this method. The sensitivity will be calculated with True Positive (TP) / TP + False Negative (FN)
Time frame
up to 1 week2
Sensitivity of Quick MRI as compared to DMSA scan in Diagnosis of Renal Scars
To establish the sensitivity of the quick renal MRI compared to the DMSA scan (using DMSA as the 'gold standard') in the diagnosis of renal scars among children with recurrent UTI. Children with recurrent Urinary Tract Infection (UTI) will undergo a clinical DMSA renal scan and quick renal MRI. The sensitivity of the quick renal MRI to detect renal scars will be determined using DMSA as the standard. The sensitivity will be calculated with TP/TP+FN.
Time frame
up to 6 months3
Specificity of Quick MRI as compared to DMSA scan in Diagnosis of Renal Scars
To establish the specificity of the quick renal MRI compared to the DMSA scan (using DMSA as the 'gold standard') in the diagnosis of renal scars among children with recurrent UTI. Children with recurrent UTI will undergo a clinical DMSA renal scan and quick renal MRI. The specificity of the quick renal MRI to detect renal scars will be determined using DMSA as the standard. The specificity will be calculated with True Negative (TN) / TN + False Positive (FP)
Time frame
up to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov