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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03910114
Enrollment
500
Registered
2019-04-10
Start date
1990-07-01
Completion date
2019-04-01
Last updated
2019-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Magnetic Resonance Imaging Contrast Agents

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).

Interventions

GBCA enhancement

GBCA enhancement

GBCA enhancement

Sponsors

Guerbet
CollaboratorINDUSTRY
Children's Hospital of Philadelphia
CollaboratorOTHER
Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 21 Years

Inclusion criteria

* Pediatric population which obtained MRI/fMRU study

Exclusion criteria

* Bilateral abnormal kidneys

Design outcomes

Primary

MeasureTime frameDescription
Dotarem TTP1 hourThe enhancement curves will provide peak enhancement values within the aorta and kidneys (Time to peak = TTP) and allow comparison between the GBCAs.
Gadovist TTP1 hourThe enhancement curves will provide peak enhancement values within the aorta and kidneys (Time to peak = TTP) and allow comparison between the GBCAs.
Magnevist TTP1 hourThe 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 Intensity1 hourThe 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 Gadovist1 hourThe 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 Gadovist1 hourThe enhancement intensity versus time will be evaluated for each GBCAs, providing an evaluation of how long renal parenchymal enhancement is maintained.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026