The Validity of the Quick Renal MRI in Pediatric Kidney Disease

NCT03959163 | Recruiting DMC FDA Device

• 3 other identifiers: 2018-0492A539800SMPH/UROLOGY/UROLOGY
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Pyelonephritis; Pyelonephritis Acute; Renal Sclerosis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

DMSA/Quick MRI

OTHER

All participants will go through DMSA and Quick MRI scan to help determine the validity of the Quick Renal MRI in pediatric kidney disease.

Diagnostic Test: Quick MRI

Interventions

Quick MRI DIAGNOSTIC_TEST

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.

DMSA/Quick MRI

Eligibility Criteria

• Age: 0 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

American Family Children's Hospital

Madison, Wisconsin, 53792, United States

RECRUITING

Related Publications (34)

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MeSH Terms

Conditions

Pyelonephritis; Nephrosclerosis

Condition Hierarchy (Ancestors)

Nephritis, Interstitial; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pyelitis; Male Urogenital Diseases

Study Officials

• Shannon Cannon, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannon Cannon, MD

CONTACT

(608) 265-8574; cannon@urology.wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 22, 2019
• Study Start: May 7, 2019
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)