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

NCT ID: NCT03910114

Last Updated: 2019-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

1990-07-01

Study Completion Date

2019-04-01

Brief Summary

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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

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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).

Conditions

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Magnetic Resonance Imaging Contrast Agents

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Dotarem Enhancement Group

Dotarem

Intervention Type DRUG

GBCA enhancement

Gadovist Enhancement Group

Gadovist

Intervention Type DRUG

GBCA enhancement

Magnevist Enhancement Group

Magnevist

Intervention Type DRUG

GBCA enhancement

Interventions

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Magnevist

GBCA enhancement

Intervention Type DRUG

Dotarem

GBCA enhancement

Intervention Type DRUG

Gadovist

GBCA enhancement

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pediatric population which obtained MRI/fMRU study

Exclusion Criteria

* Bilateral abnormal kidneys
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guerbet

INDUSTRY

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Aashim Bhatia

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Vanderbilt Childeen's Hospital

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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I002672

Identifier Type: -

Identifier Source: org_study_id

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