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

Completed · Phase 3

Conditions studied: Diagnostic Self Evaluation, Central Nervous System Diseases

In brief

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.

Key facts

Study ID

NCT01211873

Run by

Guerbet

People needed

416

Starts

2010-09-01

Expected to finish

2011-11-01

Last updated by the study team

2019-04-18

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Any condition which, based on the investigator's clinical judgement, would prevent the patient from completing all trial assessments and visits.
• Inability or unwillingness to cooperate with the requirements of this trial.

Where it is running

• 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
• QUEST Research Institute — Farmington Hills, Michigan, United States
• Gruss Magnetic resonance Research Clinic — New York, New York, United States
• WestImage - Division of Research — Cincinnati, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Texas - Health Science Center — San Antonio, Texas, United States
• UTHSCSA — San Antonio, Texas, United States
• Clinical Trials of Texas, Inc. — San Antonio, Texas, United States
• University of Washington Medical Center — Seattle, Washington, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
• Centro de Diagnóstico — Buenos Aires, Argentina
• Hospital Italiano — Buenos Aires, Argentina
• TCBA — Buenos Aires, Argentina
• Univ.-institut f.Radiodiagnostik — Salzburg, Austria
• Landesklinikum Tulln — Tulln, Austria
• University of Alabama at Birmingham, UABMC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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