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

Magnetic Resonance Imaging Contrast Agents Clinical Trial

Official title:

Contrast Enhancement Characteristics of Gadolinium-Based-Contrast-Agents (GBCA) in Functional MR Urography (fMRU)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03910114
• Other study ID #: I002672
• Status: Completed
• Start date: July 1, 1990
• Est. completion date: April 1, 2019

Study information

• Verified date: April 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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 information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Gender: All
• Age group: N/A to 21 Years

Eligibility

Inclusion Criteria:

• Pediatric population which obtained MRI/fMRU study

Exclusion Criteria:

• Bilateral abnormal kidneys

Related Conditions & MeSH terms

• Magnetic Resonance Imaging Contrast Agents

Intervention

Drug:
• Magnevist
GBCA enhancement
• Dotarem
GBCA enhancement
• Gadovist
GBCA enhancement

Locations

Country	Name	City	State
United States	Vanderbilt Childeen's Hospital	Nashville	Tennessee
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Children's Hospital of Philadelphia, Guerbet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dotarem TTP	The enhancement curves will provide peak enhancement values within the aorta and kidneys (Time to peak = TTP) and allow comparison between the GBCAs.	1 hour
Primary	Gadovist TTP	The enhancement curves will provide peak enhancement values within the aorta and kidneys (Time to peak = TTP) and allow comparison between the GBCAs.	1 hour
Primary	Magnevist TTP	The enhancement curves will provide peak enhancement values within the aorta and kidneys (Time to peak = TTP) and allow comparison between the GBCAs.	1 hour
Primary	Dotarem Time of Enhancement Intensity	The enhancement intensity versus time will be evaluated for each GBCAs, providing an evaluation of how long renal parenchymal enhancement is maintained.	1 hour
Primary	Gadovist Time of Enhancement Intensity Time of Enhancement Intensity for Gadovist	The enhancement intensity versus time will be evaluated for each GBCAs, providing an evaluation of how long renal parenchymal enhancement is maintained.	1 hour
Primary	Magnevist Time of Enhancement Intensity Time of Enhancement Intensity for Gadovist	The enhancement intensity versus time will be evaluated for each GBCAs, providing an evaluation of how long renal parenchymal enhancement is maintained.	1 hour