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Clinical Trials/NCT03910114
NCT03910114CompletedNot Applicable

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

Vanderbilt University Medical Center2 sites in 1 country500 target enrollmentStarted: July 1, 1990Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
500
Locations
2
Primary Endpoint
Dotarem TTP

Study Overview

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).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
— to 21 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Pediatric population which obtained MRI/fMRU study

Exclusion Criteria

  • Bilateral abnormal kidneys

Arms & Interventions

Dotarem Enhancement Group

Intervention: Dotarem (Drug)

Gadovist Enhancement Group

Intervention: Gadovist (Drug)

Magnevist Enhancement Group

Intervention: Magnevist (Drug)

Outcomes

Primary Outcomes

Dotarem TTP

Time Frame: 1 hour

The enhancement curves will provide peak enhancement values within the aorta and kidneys (Time to peak = TTP) and allow comparison between the GBCAs.

Gadovist TTP

Time Frame: 1 hour

The enhancement curves will provide peak enhancement values within the aorta and kidneys (Time to peak = TTP) and allow comparison between the GBCAs.

Magnevist TTP

Time Frame: 1 hour

The 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 Intensity

Time Frame: 1 hour

The 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 Gadovist

Time Frame: 1 hour

The 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 Gadovist

Time Frame: 1 hour

The enhancement intensity versus time will be evaluated for each GBCAs, providing an evaluation of how long renal parenchymal enhancement is maintained.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aashim Bhatia

Assistant Professor

Vanderbilt University Medical Center

Study Sites (2)

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