Clinical trial NCT03910114: Gadolinium-Based-Contrast-Agents (GBCA) Enhancement During MR Urography
Official title: Contrast Enhancement Characteristics of Gadolinium-Based-Contrast-Agents (GBCA) in Functional MR Urography (fMRU)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Magnetic Resonance Imaging Contrast Agents
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Guerbet
name: Children's Hospital of Philadelphia
First posted: 2019-04-10
Enrollment: 500
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric population which obtained MRI/fMRU study

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).

Eligibility criteria: Inclusion Criteria:

* Pediatric population which obtained MRI/fMRU study

Exclusion Criteria:

* Bilateral abnormal kidneys

Primary outcomes:
measure: Dotarem TTP
timeFrame: 1 hour
measure: Gadovist TTP
timeFrame: 1 hour
measure: Magnevist TTP
timeFrame: 1 hour
measure: Dotarem Time of Enhancement Intensity
timeFrame: 1 hour
measure: Gadovist Time of Enhancement Intensity Time of Enhancement Intensity for Gadovist
timeFrame: 1 hour
measure: Magnevist Time of Enhancement Intensity Time of Enhancement Intensity for Gadovist
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Childeen's Hospital
state: Tennessee
Study officials:
References: