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Trial record 53 of 95 for:    gadobenate dimeglumine

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

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ClinicalTrials.gov Identifier: NCT03910114
Recruitment Status : Completed
First Posted : April 10, 2019
Last Update Posted : April 10, 2019
Sponsor:
Collaborators:
Guerbet
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
Aashim Bhatia, Vanderbilt University Medical Center

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)


Condition or disease Intervention/treatment
Magnetic Resonance Imaging Contrast Agents Drug: Magnevist Drug: Dotarem Drug: Gadovist

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).

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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Contrast Enhancement Characteristics of Gadolinium-Based-Contrast-Agents (GBCA) in Functional MR Urography (fMRU)
Actual Study Start Date : July 1, 1990
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : April 1, 2019

Group/Cohort Intervention/treatment
Dotarem Enhancement Group Drug: Dotarem
GBCA enhancement

Gadovist Enhancement Group Drug: Gadovist
GBCA enhancement

Magnevist Enhancement Group Drug: Magnevist
GBCA enhancement




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Pediatric population which obtained MRI/fMRU study
Criteria

Inclusion Criteria:

  • Pediatric population which obtained MRI/fMRU study

Exclusion Criteria:

  • Bilateral abnormal kidneys

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03910114


Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
United States, Tennessee
Vanderbilt Childeen's Hospital
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Guerbet
Children's Hospital of Philadelphia

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Responsible Party: Aashim Bhatia, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03910114     History of Changes
Other Study ID Numbers: I002672
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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