Gadolinium-Based-Contrast-Agents (GBCA) Enhancement During MR Urography
- Conditions
- Magnetic Resonance Imaging Contrast Agents
- Interventions
- Registration Number
- NCT03910114
- Lead Sponsor
- Vanderbilt University Medical Center
- Brief Summary
Rationale: Dotarem provides superior enhancement characteristics compared to other GBCA in fMRU
Specific Aims: Compare enhancement characteristics of Dotarem to other GBCAs in the kidneys used in fMRU
Primary Objectives: Review functional analysis curves and data of fMRU studies and determine enhancement characteristics in the kidneys of the three GBCAs (Dotarem, Gadovist, Magnevist)
- Detailed Description
A retrospective review will be performed of all functional MRI urography (fMRU) cases at two institutions (Children's Hospital of Philadelphia and Vanderbilt Children's Hospital). Over 1000 studies have been performed between the institutions and the normal studies will be selected based on radiology reports and reviewed to confirm they are normal. The fMRU is performed with Gadolinium based contrast agents (GBCAs), initially was performed with Magnevist, then switched to Gadavist, and most recently converted to Dotarem. The fMRU software for analysis of the functional data provides enhancement curves of the aorta and kidneys. fMRU enhancement curves are generated by drawing regions of interest in the aorta and renal parenchyma and calculating the average signal intensity over time. A comparison of the enhancement curves will be performed of the three GBCAs in the normal pediatric population. The enhancement curves will provide peak enhancement values within the aorta and kidneys (Time to peak = TTP) and allow comparison between the GBCAs. The enhancement intensity versus time will be evaluated for each GBCAs, providing an evaluation of how long renal parenchymal enhancement is maintained. Additional functional data will be reviewed such as calyceal transit time (CTT) and renal transit time (RTT).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
- Pediatric population which obtained MRI/fMRU study
- Bilateral abnormal kidneys
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Gadovist Enhancement Group Gadovist - Magnevist Enhancement Group Magnevist - Dotarem Enhancement Group Dotarem -
- Primary Outcome Measures
Name Time Method Dotarem TTP 1 hour The enhancement curves will provide peak enhancement values within the aorta and kidneys (Time to peak = TTP) and allow comparison between the GBCAs.
Gadovist TTP 1 hour The enhancement curves will provide peak enhancement values within the aorta and kidneys (Time to peak = TTP) and allow comparison between the GBCAs.
Magnevist TTP 1 hour The enhancement curves will provide peak enhancement values within the aorta and kidneys (Time to peak = TTP) and allow comparison between the GBCAs.
Dotarem Time of Enhancement Intensity 1 hour The enhancement intensity versus time will be evaluated for each GBCAs, providing an evaluation of how long renal parenchymal enhancement is maintained.
Gadovist Time of Enhancement Intensity Time of Enhancement Intensity for Gadovist 1 hour The enhancement intensity versus time will be evaluated for each GBCAs, providing an evaluation of how long renal parenchymal enhancement is maintained.
Magnevist Time of Enhancement Intensity Time of Enhancement Intensity for Gadovist 1 hour The enhancement intensity versus time will be evaluated for each GBCAs, providing an evaluation of how long renal parenchymal enhancement is maintained.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Vanderbilt Childeen's Hospital
🇺🇸Nashville, Tennessee, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States