The Validity of the Quick Renal MRI in Pediatric Kidney Disease

Обзор

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).

Подробное описание

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.

Вмешательства

• Диагностический тест 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

Первичные конечные точки

• Sensitivity of Quick MRI as Compared to DMSA scan in Diagnosis of Suspected Acute Pyelonephritis [Срок оценки: up to 1 week]
• Sensitivity of Quick MRI as compared to DMSA scan in Diagnosis of Renal Scars [Срок оценки: up to 6 months]
• Specificity of Quick MRI as compared to DMSA scan in Diagnosis of Renal Scars [Срок оценки: up to 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• American Family Children's Hospital — Madison

Публикации

• 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. PMID 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. PMID 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. Epu PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 19013606

Идентификаторы

NCT: NCT03959163 · 2018-0492 · A539800 · SMPH/UROLOGY/UROLOGY

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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