The Validity of the Quick Renal MRI in Pediatric Kidney Disease

Pyelonephritis Clinical Trial

Official title:

The Validity of the Quick Renal MRI in Pediatric Kidney Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03959163
• Other study ID #: 2018-0492
• Secondary ID: A539800SMPH/UROL
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2019
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: University of Wisconsin, Madison
• Contact: Shannon Cannon, MD
• Phone: (608) 265-8574
• Email: cannon[@]urology.wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

Children born with congenital anomalies of the urinary tract are susceptible to kidney infections and scarring. They form a high risk group for developing renal insufficiency in adulthood. A basic tenet in pediatric urology is that kidney infections should be prevented and otherwise promptly identified to minimize the risk of acquiring renal scars and permanent tissue damage.

The current radiologic standard for renal infection and scarring is the 99mTechnetium-dimercaptosuccinic acid (99mTc- DMSA) renal scan. This exam requires an intravenous injection, occurs over a 3 hour period, involves exposure to radiation, and can require sedation of young children. The investigators propose a new imaging method 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 the DMSA 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.

There are two separate aims to this study, and study activities/schedule will vary depending on which aim the participant is in:

Aim 1: Inpatients presenting with acute pyelonephritis or possible acute pyelonephritis will be approached about the study. After participant's consent to the study, they will complete a clinical DMSA scan and quick MRI for the study. The DMSA scan and quick MRI will be completed within one week of each other, and ideally during the participant's inpatient stay.

Aim 2: Patients presenting to clinic for visits regarding their renal scarring will be approached about the study. If participant's consent to the study and if possible, they will schedule the quick MRI during this visit. The clinical DMSA scan and quick MRI should be completed within 6 months of each other for this patient population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 21 Years

Eligibility

Inclusion Criteria:

• Aim 1:

• Patient is admitted to American Family Children's Hospital for a febrile UTI, suspected pyelonephritis, or diagnosed pyelonephritis

• Undergoing clinical DMSA scan

• Aim 2:

• Undergoing DMSA scans as a part of their routine clinical care

• History of more than one UTI in the past year

Exclusion Criteria:

• Aim 1:

• No evidence of pyuria on their urine analysis

• Negative urine culture

• Not comfortable with having a Quick MRI performed

• Both aims:

• Contraindications to MRI

Related Conditions & MeSH terms

• Kidney Diseases
• Pyelonephritis
• Pyelonephritis Acute
• Renal Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United States	American Family Children's Hospital	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	up to 1 week
Primary	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.	up to 6 months
Primary	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)	up to 6 months