Recruiting

Quick Renal MRI

Sponsor:

University of Wisconsin, Madison

Code:

NCT03959163

Conditions

Pyelonephritis

Pyelonephritis Acute

Renal Sclerosis

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

Quick MRI

Study Details

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

Study ID

NCT03959163

Start date

May 7, 2019

Status verified date

Apr, 2024

Completion date

Jan, 2025

Anticipated

Primary completion date

Jan, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: 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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Shannon Cannon, MD

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

Locations

American Family Children's Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Jennifer Wang

608-265-3834jtwang@ortho.wisc.edu

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Apr 3, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2024-04-03.