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Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions | Clinical Trials | Clareo Health

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Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions

Safety and Efficacy Evaluation of DOTAREM® in Magnetic Resonance Imaging (MRI) in Patients With Central Nervous System (CNS) Lesions.

NCT01211873•Guerbet

View on ClinicalTrials.gov

Summary

The purpose of this study is to look at the safety (what are the side effects)and efficacy (how well does it work) of Dotarem® when used in taking images of the brain / spine. The results will be compared to the results of MRI taken without Dotarem.

Detailed Description

This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Dotarem®. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Dotarem® when used for taking images of the brain and spine. The results of the MRI will be compared to the results of images taken without Dotarem®.

Eligibility

Age

2 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult subject and pediatric subjects (aged greater than or equal to two (2) years).
•Is referred for a contrast-enhanced MRI of the CNS based on the results of a previous imaging procedure.
•Female of childbearing potential patients must have effective contraception (contraceptive pill or intra-uterine device) or be surgically sterilized or post-menopausal (minimum 12 months amenorrhea), or have a documented negative urine pregnancy test within 24 hours prior to study MRI.
•Has been fully informed about the study, and has consented to participate.

Exclusion Criteria

•Having acute or chronic grade IV or V renal insufficiency.
•Known class III/IV congestive heart failure.
•Suffering from long QT syndrome.
•Unstable health condition or circumstances (e.g. suffering from severe claustrophobia).
•Having any contraindications to MRI such as a pace-maker, magnetic material or any other conditions that would preclude proximity to a strong magnetic field.
•Known allergy to Gadolinium chelates.
•Having received any contrast agent within 3 days prior to study contrast administration, or is scheduled to receive any contrast agent within 24 hours after the study contrast administration.
•Pregnant, breast feeding, or planning to become pregnant during the trial.
•Previously participated in this trial.
•Having participated within 30 days in another clinical trial involving an investigational drug.
+2 more criteria

Locations (52)

University of Alabama at Birmingham, UABMC

Birmingham, Alabama, United States

University Medical Center

Tucson, Arizona, United States

University medical center

Tucson, Arizona, United States

Desert Medical Imaging

Indian Wells, California, United States

Sunrise Clinical Research, Inc.

Hollywood, Florida, United States

Children's Memorial Hospital

Chicago, Illinois, United States

Precise Clinical Research Solutions

Topeka, Kansas, United States

University of Louisville Hospital

Louisville, Kentucky, United States

Neurocare Center for Research

Brookline, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Key Dates

Start Date

September 1, 2010

Primary Completion Date

November 1, 2011

Completion Date

November 1, 2011

Last Updated

April 18, 2019

Enrollment

416

ACTUAL participants

Conditions

Diagnostic Self EvaluationCentral Nervous System Diseases

Interventions

Dotarem (gadoterate meglumine)

DRUG

Magnevist (gadopentetate dimeglumine)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions

Inclusion Criteria

Exclusion Criteria

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