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The Validity of the Quick Renal MRI in Pediatric Kidney Disease

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ClinicalTrials.gov Identifier: NCT03959163
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE May 20, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date May 22, 2019
Actual Study Start Date  ICMJE May 7, 2019
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Validity of the Quick Renal MRI in Pediatric Kidney Disease
Official Title  ICMJE The Validity of the Quick Renal MRI in Pediatric Kidney Disease
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Pyelonephritis
  • Pyelonephritis Acute
  • Renal Sclerosis
Intervention  ICMJE 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.
Study Arms  ICMJE DMSA/Quick MRI
All participants will go through DMSA and Quick MRI scan to help determine the validity of the Quick Renal MRI in pediatric kidney disease.
Intervention: Diagnostic Test: Quick MRI
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2023
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

    • Patients being seen at the American Family Children's Hospital Spina Bifida Multi-Disciplinary Clinic for routine follow up
    • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jennifer Wang 608-265-3834 jtwang@ortho.wisc.edu
Contact: Thomas Leffler 608-262-0713 leffler@urology.wisc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03959163
Other Study ID Numbers  ICMJE 2018-0492
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ruthie Su, MD University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP