NCT03959163 · University of Wisconsin, Madison
The Validity of the Quick Renal MRI in Pediatric Kidney Disease
What this study is about
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.
View original scientific description
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).
Interventions
DIAGNOSTIC_TEST
Quick MRI
A 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.
Primary outcome measures
Sensitivity of Quick MRI as Compared to DMSA scan in Diagnosis of Suspected Acute Pyelonephritis
Time frame: up to 1 week
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)
Sensitivity of Quick MRI as compared to DMSA scan in Diagnosis of Renal Scars
Time frame: up to 6 months
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.
Specificity of Quick MRI as compared to DMSA scan in Diagnosis of Renal Scars
Time frame: up to 6 months
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- No evidence of pyuria on their urine analysis
- Negative urine culture
- Not comfortable with having a Quick MRI performed
- Contraindications to MRI
Where
- Madison, Wisconsin
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 3, 2024 · Source of record for eligibility and locations