Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions
- Conditions
- Diagnostic Self EvaluationCentral Nervous System Diseases
- Interventions
- Registration Number
- NCT01211873
- Lead Sponsor
- Guerbet
- Brief 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®.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 416
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dotarem (gadoterate meglumine ) Dotarem (gadoterate meglumine) Dotarem and Magnevist were randomised as 2:1 ratio for adult patients. Magnevist (gadopentetate dimeglumine) Magnevist (gadopentetate dimeglumine) Dotarem and Magnevist were randomised as 2:1 ratio Dotarem 2 (gadoterate meglumine ) Dotarem (gadoterate meglumine) Pediatric patients were assigned to Dotarem group only.
- Primary Outcome Measures
Name Time Method MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both "Pre" and "Paired" Evaluation up to 24 hours To demonstrate the superiority of combined unenhanced and Dotarem enhanced MRI (PAIRED) compared to unenhanced MRI (PRE) in terms of lesion visualization.
Unenhanced MRI refers to MRI before administration of contrast agent. Enhanced MRI refers to MRI after contrast agent injection. "Pre" refers to unenhanced MRI. "PAIRED" refer to combined unenhanced and enhanced MRI.
The measure used a specific scale with 3-point levels to assess lesion visualization. At lesion level, the scale range is from 0 through 1 to 2. Score 0 means a worse outcome and score 2 means a better outcome. Patient score is the sum of all lesion scores. Up to 5 of the largest representative lesions were assessed. At patient level, the maximum score is 10, minimum score is 0.
- Secondary Outcome Measures
Name Time Method Image Quality Score up to 24 hours Image quality was evaluated for each lesion according to a 3-point scale with the following grades; poor (1), fair (2) or good (3), and an overall score per patient was calculated. At patient level, the maximum score is 3, minimum score is 1. Higher scores mean a better image quality.
Diagnostic Confidence Score up to 24 hours Level of diagnostic confidence when evaluating the MRI modalities was graded using a 5-point scale as nil (1), poor (2), moderate (3), high (4) and excellent (5).
Number of Lesions up to 24 hours The number of lesions for which observations could be made was calculated for each MRI modality and results are summarized per patient
Trial Locations
- Locations (52)
Children's Memorial Hospital
🇺🇸Chicago, Illinois, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Medical University of Vienna
🇦🇹Vienna, Austria
Departamento de Neuroradiologia
🇨🇱Santiago, Chile
Hôpital Gui De Chauliac
🇫🇷Montpellier, France
Gruss Magnetic resonance Research Clinic
🇺🇸New York, New York, United States
Hospital Italiano
🇦🇷Buenos Aires, Argentina
Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
🇧🇷São Paulo, Brazil
Landesklinikum Tulln
🇦🇹Tulln, Austria
Desert Medical Imaging
🇺🇸Indian Wells, California, United States
University medical center
🇺🇸Tucson, Arizona, United States
Krankenhaus Nordwest GmbH
🇩🇪Frankfurt, Germany
Centro de Diagnóstico
🇦🇷Buenos Aires, Argentina
Precise Clinical Research Solutions
🇺🇸Topeka, Kansas, United States
Hôpital Roger Salengro- CRHU de Lille
🇫🇷Lille, France
TCBA
🇦🇷Buenos Aires, Argentina
Fédération d'Imagerie Médicale,Hôpital Pontchaillou
🇫🇷Rennes, France
Hôpital Pellegrin
🇫🇷Bordeaux, France
Instituto de Neurocirugia Dr. Asenjo,
🇨🇱Santiago, Chile
Universidade Federal de São Paulo / UNIFESP
🇧🇷São Paulo, Brazil
University Hospital LMU Munich
🇩🇪Munich, Germany
University Hospital Mannheim
🇩🇪Mannheim, Germany
University Medical Center
🇺🇸Tucson, Arizona, United States
Neurocare Center for Research
🇺🇸Brookline, Massachusetts, United States
QUEST Research Institute
🇺🇸Farmington Hills, Michigan, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
Univ.-institut f.Radiodiagnostik
🇦🇹Salzburg, Austria
Centre Hospitalier Sainte Anne
🇫🇷Paris, France
Radiologie A - Hôpital de la Milétrie
🇫🇷Poitiers, France
University Hospital Frankfurt
🇩🇪Frankfurt/Main, Germany
University of Leipzig
🇩🇪Leipzig, Germany
University of Heidelberg
🇩🇪Heidelberg, Germany
Istituto di Radiologia
🇮🇹Firenze, Italy
Azienda Ospedaliera S. Andrea
🇮🇹Roma, Italy
Neuroradiologia,II Università Di Napoli
🇮🇹Napoli, Italy
Hospital Vall d´Hebron
🇪🇸Barcelona, Spain
University Department of Radiology
🇬🇧Cambridge, United Kingdom
Hospital Clinico Universitario San Carlos
🇪🇸Madrid, Spain
Complejo Hospitalario Universitario de Vigo - Serviço de radiologia
🇪🇸Vigo, Spain
Seoul National Unversity Hospital
🇰🇷Seoul, Korea, Republic of
Sunrise Clinical Research, Inc.
🇺🇸Hollywood, Florida, United States
University Hospital Charite
🇩🇪Berlin, Germany
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Ohio State University
🇺🇸Columbus, Ohio, United States
University of Louisville Hospital
🇺🇸Louisville, Kentucky, United States
WestImage - Division of Research
🇺🇸Cincinnati, Ohio, United States
University of Alabama at Birmingham, UABMC
🇺🇸Birmingham, Alabama, United States
University of Texas - Health Science Center
🇺🇸San Antonio, Texas, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, United States
UTHSCSA
🇺🇸San Antonio, Texas, United States