Clinical trial NCT03959163: The Validity of the Quick Renal MRI in Pediatric Kidney Disease
Official title: The Validity of the Quick Renal MRI in Pediatric Kidney Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pyelonephritis
Pyelonephritis Acute
Renal Sclerosis
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of Quick MRI as Compared to DMSA scan in Diagnosis of Suspected Acute Pyelonephritis
timeFrame: up to 1 week
measure: Sensitivity of Quick MRI as compared to DMSA scan in Diagnosis of Renal Scars
timeFrame: up to 6 months
measure: Specificity of Quick MRI as compared to DMSA scan in Diagnosis of Renal Scars
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: American Family Children's Hospital
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Shannon Cannon, MD
role: PRINCIPAL_INVESTIGATOR
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