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PyelonephritisNCT03959163

The Validity of the Quick Renal MRI in Pediatric Kidney Disease

A study testing Quick MRI in people with Pyelonephritis and Pyelonephritis Acute, run by University of Wisconsin, Madison at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 0 to 21 years
What is being tested?
Quick MRI
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
7 May 2019to Jan 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shannon Cannon, MD contact

(608) 265-8574

cannon@urology.wisc.edu

United States1 site, 1 recruiting
  • American Family Children's Hospital

    Madison, Wisconsin, 53792

    Jennifer Wang, 608-265-3834, jtwang@ortho.wisc.edu

    Recruiting

Other trials in United States

About this study

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).

Read the 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.

Being tested
Quick MRI
Medical subject headings
Pyelonephritis, Nephrosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quick MRIDiagnostic 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.

Study groups in NCT03959163
Study groupRoleWhat they receive
DMSA/Quick MRIOtherAll participants will go through DMSA and Quick MRI scan to help determine the validity of the Quick Renal MRI in pediatric kidney disease.
Receives: Diagnostic Test: Quick MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: up to 1 week

  2. 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.

    Measured: up to 6 months

  3. 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)

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2019
  2. Study start7 May 2019
  3. Primary completionJan 2025 (estimated)
  4. Study completionJan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03959163
Sponsor's protocol ID
2018-0492
Other IDs
A539800, SMPH/UROLOGY/UROLOGY
Status last verified
Apr 2024
First submitted
20 May 2019
Last updated
3 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Freedman AL; Urologic Diseases in America Project. Urologic diseases in North America Project: trends in resource utilization for urinary tract infections in children. J Urol. 2005 Mar;173(3):949-54. doi: 10.1097/01.ju.0000152092.03931.9a.

    PubMed 15711347
  • Hoberman A, Chao HP, Keller DM, Hickey R, Davis HW, Ellis D. Prevalence of urinary tract infection in febrile infants. J Pediatr. 1993 Jul;123(1):17-23. doi: 10.1016/s0022-3476(05)81531-8.

    PubMed 8320616
  • Sood A, Penna FJ, Eleswarapu S, Pucheril D, Weaver J, Abd-El-Barr AE, Wagner JC, Lakshmanan Y, Menon M, Trinh QD, Sammon JD, Elder JS. Incidence, admission rates, and economic burden of pediatric emergency department visits for urinary tract infection: data from the nationwide emergency department sample, 2006 to 2011. J Pediatr Urol. 2015 Oct;11(5):246.e1-8. doi: 10.1016/j.jpurol.2014.10.005. Epub 2015 Feb 7.

    PubMed 26005017
  • Copp HL, Halpern MS, Maldonado Y, Shortliffe LD. Trends in hospitalization for pediatric pyelonephritis: a population based study of California from 1985 to 2006. J Urol. 2011 Sep;186(3):1028-34. doi: 10.1016/j.juro.2011.04.101. Epub 2011 Jul 23.

    PubMed 21784477
  • Chen MJ, Cheng HL, Chiou YY. Risk factors for renal scarring and deterioration of renal function in primary vesico-ureteral reflux children: a long-term follow-up retrospective cohort study. PLoS One. 2013;8(2):e57954. doi: 10.1371/journal.pone.0057954. Epub 2013 Feb 28.

    PubMed 23469116
  • Rushton HG, Majd M. Dimercaptosuccinic acid renal scintigraphy for the evaluation of pyelonephritis and scarring: a review of experimental and clinical studies. J Urol. 1992 Nov;148(5 Pt 2):1726-32. doi: 10.1016/s0022-5347(17)37014-3.

    PubMed 1331545
  • Hari P, Bagga A. Antimicrobial prophylaxis for children with vesicoureteral reflux. N Engl J Med. 2014 Sep 11;371(11):1071-2. doi: 10.1056/NEJMc1408559. No abstract available.

    PubMed 25207775
  • Faust WC, Diaz M, Pohl HG. Incidence of post-pyelonephritic renal scarring: a meta-analysis of the dimercapto-succinic acid literature. J Urol. 2009 Jan;181(1):290-7; discussion 297-8. doi: 10.1016/j.juro.2008.09.039. Epub 2008 Nov 14.

    PubMed 19013606
  • Rushton HG, Majd M, Jantausch B, Wiedermann BL, Belman AB. Renal scarring following reflux and nonreflux pyelonephritis in children: evaluation with 99mtechnetium-dimercaptosuccinic acid scintigraphy. J Urol. 1992 May;147(5):1327-32. doi: 10.1016/s0022-5347(17)37555-9.

    PubMed 1314912
  • Lee LC, Lorenzo AJ, Koyle MA. The role of voiding cystourethrography in the investigation of children with urinary tract infections. Can Urol Assoc J. 2016 May-Jun;10(5-6):210-214. doi: 10.5489/cuaj.3610.

    PubMed 27713802
  • Fillion ML, Watt CL, Gupta IR. Vesicoureteric reflux and reflux nephropathy: from mouse models to childhood disease. Pediatr Nephrol. 2014 Apr;29(4):757-66. doi: 10.1007/s00467-014-2761-3. Epub 2014 Feb 6.

    PubMed 24500705
  • McKibben MJ, Seed P, Ross SS, Borawski KM. Urinary Tract Infection and Neurogenic Bladder. Urol Clin North Am. 2015 Nov;42(4):527-36. doi: 10.1016/j.ucl.2015.05.006. Epub 2015 Jul 7.

    PubMed 26475949
  • Oakeshott P, Hunt GM, Poulton A, Reid F. Expectation of life and unexpected death in open spina bifida: a 40-year complete, non-selective, longitudinal cohort study. Dev Med Child Neurol. 2010 Aug;52(8):749-53. doi: 10.1111/j.1469-8749.2009.03543.x. Epub 2009 Dec 9.

    PubMed 20015251
  • Woodhouse CR. Myelomeningocele in young adults. BJU Int. 2005 Feb;95(2):223-30. doi: 10.1111/j.1464-410X.2005.05374.x. No abstract available.

    PubMed 15667645
  • Wang HH, Lloyd JC, Wiener JS, Routh JC. Nationwide Trends and Variations in Urological Surgical Interventions and Renal Outcome in Patients with Spina Bifida. J Urol. 2016 Apr;195(4 Pt 2):1189-94. doi: 10.1016/j.juro.2015.11.033. Epub 2016 Feb 28.

    PubMed 26926542

Questions about this trial

What is this clinical trial studying?

A study testing Quick MRI in people with Pyelonephritis and Pyelonephritis Acute, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shannon Cannon, MD ((608) 265-8574, cannon@urology.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity of Quick MRI as Compared to DMSA scan in Diagnosis of Suspected Acute Pyelonephritis (time frame: up to 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03959163, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.

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