Clinical trial NCT01211873: Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions
Official title: Safety and Efficacy Evaluation of DOTAREM® in Magnetic Resonance Imaging (MRI) in Patients With Central Nervous System (CNS) Lesions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diagnostic Self Evaluation
Central Nervous System Diseases
Keywords: CNS
Contrast Agent
MRI
Dotarem
Magnevist
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2010-09-30
Enrollment: 416
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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®.

Eligibility criteria: 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.

Primary outcomes:
measure: MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both "Pre" and "Paired" Evaluation
timeFrame: up to 24 hours
Secondary outcomes:
measure: Image Quality Score
timeFrame: up to 24 hours
measure: Diagnostic Confidence Score
timeFrame: up to 24 hours
measure: Number of Lesions
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham, UABMC
state: Alabama
city: Tucson
country: United States
facility: University Medical Center
state: Arizona
city: Tucson
country: United States
facility: University medical center
state: Arizona
city: Indian Wells
country: United States
facility: Desert Medical Imaging
state: California
city: Hollywood
country: United States
facility: Sunrise Clinical Research, Inc.
state: Florida
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
city: Topeka
country: United States
facility: Precise Clinical Research Solutions
state: Kansas
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: Brookline
country: United States
facility: Neurocare Center for Research
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Farmington Hills
country: United States
facility: QUEST Research Institute
state: Michigan
city: New York
country: United States
facility: Gruss Magnetic resonance Research Clinic
state: New York
city: Cincinnati
country: United States
facility: WestImage - Division of Research
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: San Antonio
country: United States
facility: University of Texas - Health Science Center
state: Texas
city: San Antonio
country: United States
facility: UTHSCSA
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Centro de Diagnóstico
city: Buenos Aires
country: Argentina
facility: Hospital Italiano
city: Buenos Aires
country: Argentina
facility: TCBA
city: Salzburg
country: Austria
facility: Univ.-institut f.Radiodiagnostik
city: Tulln
country: Austria
facility: Landesklinikum Tulln
city: Vienna
country: Austria
facility: Medical University of Vienna
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo / UNIFESP
city: Santiago
country: Chile
facility: Departamento de Neuroradiologia
city: Santiago
country: Chile
facility: Instituto de Neurocirugia Dr. Asenjo,
city: Bordeaux
country: France
facility: Hôpital Pellegrin
city: Lille
country: France
facility: Hôpital Roger Salengro- CRHU de Lille
city: Montpellier
country: France
facility: Hôpital Gui De Chauliac
city: Paris
country: France
facility: Centre Hospitalier Sainte Anne
city: Poitiers
country: France
facility: Radiologie A - Hôpital de la Milétrie
city: Rennes
country: France
facility: Fédération d'Imagerie Médicale,Hôpital Pontchaillou
city: Berlin
country: Germany
facility: University Hospital Charite
city: Frankfurt/Main
country: Germany
facility: University Hospital Frankfurt
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest GmbH
city: Heidelberg
country: Germany
facility: University of Heidelberg
city: Leipzig
country: Germany
facility: University of Leipzig
city: Mannheim
country: Germany
facility: University Hospital Mannheim
city: Munich
country: Germany
facility: University Hospital LMU Munich
city: Firenze
country: Italy
facility: Istituto di Radiologia
city: Napoli
country: Italy
facility: Neuroradiologia,II Università Di Napoli
city: Roma
country: Italy
facility: Azienda Ospedaliera S. Andrea
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National Unversity Hospital
city: Barcelona
country: Spain
facility: Hospital Vall d´Hebron
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo - Serviço de radiologia
city: Cambridge
country: United Kingdom
facility: University Department of Radiology
Study officials:
affiliation: University of Wasington School of Medicine
name: Ken Maravilla, MD
role: PRINCIPAL_INVESTIGATOR
References: