Gadolinium-Based-Contrast-Agents (GBCA) Enhancement During MR Urography

Vanderbilt University Medical Center

Status: Completed

Conditions: Magnetic Resonance Imaging Contrast Agents

Treatments: Drug: Dotarem; Drug: Gadovist; Drug: Magnevist

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03910114

I002672

Details and patient eligibility

About

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)

Full 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).

Enrollment: 500 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pediatric population which obtained MRI/fMRU study

Exclusion criteria

• Bilateral abnormal kidneys

Trial design

500 participants in 3 patient groups

Dotarem Enhancement Group

Treatment:

Drug: Dotarem

Gadovist Enhancement Group

Treatment:

Drug: Gadovist

Magnevist Enhancement Group

Treatment:

Drug: Magnevist