Gadolinium-Based-Contrast-Agents (GBCA) Enhancement During MR Urography
April 8, 2019 updated by: Aashim Bhatia, Vanderbilt University Medical Center
Contrast Enhancement Characteristics of Gadolinium-Based-Contrast-Agents (GBCA) in Functional MR Urography (fMRU)
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)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States
- Children's Hospital of Philadelphia
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt Childeen's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 21 years (ADULT, CHILD)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Pediatric population which obtained MRI/fMRU study
Description
Inclusion Criteria:
- Pediatric population which obtained MRI/fMRU study
Exclusion Criteria:
- Bilateral abnormal kidneys
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Dotarem Enhancement Group
|
GBCA enhancement
|
|
Gadovist Enhancement Group
|
GBCA enhancement
|
|
Magnevist Enhancement Group
|
GBCA enhancement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 hour
|
|
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.
|
1 hour
|
|
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.
|
1 hour
|
|
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.
|
1 hour
|
|
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.
|
1 hour
|
|
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.
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 1, 1990
Primary Completion (ACTUAL)
April 1, 2019
Study Completion (ACTUAL)
April 1, 2019
Study Registration Dates
First Submitted
April 3, 2019
First Submitted That Met QC Criteria
April 8, 2019
First Posted (ACTUAL)
April 10, 2019
Study Record Updates
Last Update Posted (ACTUAL)
April 10, 2019
Last Update Submitted That Met QC Criteria
April 8, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- I002672 (Other Grant/Funding Number: Guerbet)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.