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.
Minimum age: 2 Years.
Maximum age: N/A.
Gender(s): Both.
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.
- 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.
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
Medical University of Vienna, Vienna, Austria
Hospital das ClÃnicas da Faculdade de Medicina da Universidade de Sao Paulo, São Paulo, Brazil
Universidade Federal de São Paulo / UNIFESP, São Paulo, Brazil
Departamento de Neuroradiologia, Santiago, Chile
Instituto de Neurocirugia Dr. Asenjo,, Santiago, Chile
Hôpital Pellegrin, Bordeaux, France
Hôpital Roger Salengro- CRHU de Lille, Lille, France
Hôpital Gui De Chauliac, Montpellier, France
Centre Hospitalier Sainte Anne, Paris, France
Radiologie A - Hôpital de la Milétrie, Poitiers, France
Fédération d'Imagerie Médicale,Hôpital Pontchaillou, Rennes, France
University Hospital Charite, Berlin, Germany
University Hospital Frankfurt, Frankfurt/Main, Germany
Krankenhaus Nordwest GmbH, Frankfurt, Germany
University of Heidelberg, Heidelberg, Germany
University of Leipzig, Leipzig, Germany
University Hospital Mannheim, Mannheim, Germany
University Hospital LMU Munich, Munich, Germany
Istituto di Radiologia, Firenze, Italy
Neuroradiologia,II Università Di Napoli, Napoli, Italy
Azienda Ospedaliera S. Andrea, Roma, Italy
Samsung Medical Center, Seoul, Korea, Republic of
Seoul National Unversity Hospital, Seoul, Korea, Republic of
Hospital Vall d´Hebron, Barcelona, Spain
Hospital Clinico Universitario San Carlos, Madrid, Spain
Complejo Hospitalario Universitario de Vigo - Serviço de radiologia, Vigo Pontevedra, Spain
University Department of Radiology, Cambridge, United Kingdom
University of Alabama at Birmingham, UABMC, Birmingham, Alabama 35233, United States
University Medical Center, Tucson, Arizona 47404, United States
University medical center, Tucson, Arizona 85724, United States
Desert Medical Imaging, Indian Wells, California 47404, United States
Sunrise Clinical Research, Inc., Hollywood, Florida 33021, United States
Children's Memorial Hospital, Chicago, Illinois 60614, United States
Precise Clinical Research Solutions, Topeka, Kansas 66604, United States
University of Louisville Hospital, Louisville, Kentucky 40202, United States
Neurocare Center for Research, Brookline, Massachusetts 02446, United States
University of Michigan, Ann Arbor, Michigan 48109, United States
QUEST Research Institute, Farmington Hills, Michigan 48334, United States
Gruss Magnetic resonance Research Clinic, NYC, New York 10461, United States
WestImage - Division of Research, Cincinnati, Ohio 45248, United States
Ohio State University, Columbus, Ohio 47404, United States
Medical University of South Carolina, Charleston, South Carolina 29425, United States
Clinical Trials of Texas, Inc., San Antonio, Texas 78229, United States
University of Texas - Health Science Center, San Antonio, Texas 47404, United States
UTHSCSA, San Antonio, Texas 47404, United States
University of Washington Medical Center, Seattle, Washington 98195, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin 53792, United States