Gadolinium-Based-Contrast-Agents (GBCA) Enhancement During MR Urography
Contrast Enhancement Characteristics of Gadolinium-Based-Contrast-Agents (GBCA) in Functional MR Urography (fMRU)
1 other identifier
observational
500
1 country
2
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 1990
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1990
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 3, 2019
CompletedFirst Posted
Study publicly available on registry
April 10, 2019
CompletedApril 10, 2019
April 1, 2019
28.8 years
April 3, 2019
April 8, 2019
Conditions
Outcome Measures
Primary Outcomes (6)
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
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
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
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
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
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
Study Arms (3)
Dotarem Enhancement Group
Gadovist Enhancement Group
Magnevist Enhancement Group
Interventions
Eligibility Criteria
Pediatric population which obtained MRI/fMRU study
You may qualify if:
- Pediatric population which obtained MRI/fMRU study
You may not qualify if:
- Bilateral abnormal kidneys
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt University Medical Centerlead
- Guerbetcollaborator
- Children's Hospital of Philadelphiacollaborator
Study Sites (2)
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Vanderbilt Childeen's Hospital
Nashville, Tennessee, 37232, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 3, 2019
First Posted
April 10, 2019
Study Start
July 1, 1990
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
April 10, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share