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

Purpose

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.

Condition	Intervention	Phase
Diagnostic Imaging Central Nervous System Diseases	Drug: Dotarem (gadoterate meglumine) Drug: Magnevist (gadopentetate dimeglumine)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic
Official Title:	Safety and Efficacy Evaluation of DOTAREM® in Magnetic Resonance Imaging (MRI) in Patients With Central Nervous System (CNS) Lesions.

Resource links provided by NLM:

MedlinePlus related topics: Neurologic Diseases

Drug Information available for: Meglumine Gadopentetate dimeglumine Gadoterate meglumine Gadobenate Dimeglumine

U.S. FDA Resources

Further study details as provided by Guerbet:

Primary Outcome Measures:

MRI lesion visualization with 3 parameters (lesion border delineation, internal morphology and degree of contrast enhancement) on 3-point scales. [ Time Frame: up to 24 hours ] [ Designated as safety issue: No ]
To demonstrate the superiority of combined unenhanced and Dotarem enhanced MRI compared to unenhaced MRI in terms of lesion visulization.

Secondary Outcome Measures:

The quality of images on 3-point scale: poor, fair or good. [ Time Frame: up to 24 hours ] [ Designated as safety issue: No ]
Level of diagnostic confidence on 5-point scale ranging from nil to excellent with poor, moderate and high as intermediate grades. [ Time Frame: up to 24 hours ] [ Designated as safety issue: No ]
Number of lesions with MRI signal intensity changes after contrast agent injection. [ Time Frame: up to 24 hours ] [ Designated as safety issue: No ]
Number of participants with Adverse Events as a measure of safety and tolerability. [ Time Frame: up to 29 days ] [ Designated as safety issue: Yes ]
Measure vital signs (supine systolic and diastolic blood pressures, pulse). [ Time Frame: up to 24 hours ] [ Designated as safety issue: Yes ]
Measure ECG [ Time Frame: up to 24 hours ] [ Designated as safety issue: Yes ]
Injection-site tolerance on the Visual Analog Scale from 0 (no pain) to 10 (maximal pain). [ Time Frame: up to 24 hours ] [ Designated as safety issue: Yes ]
Measure blood sample. [ Time Frame: up to 24 hours ] [ Designated as safety issue: Yes ]

Enrollment:	416
Study Start Date:	September 2010
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dotarem (gadoterate meglumine )	Drug: Dotarem (gadoterate meglumine) 0.1 mmol/kg by body weight, single IV injection Other Name: Dotarem
Active Comparator: Magnevist (gadopentetate dimeglumine)	Drug: Magnevist (gadopentetate dimeglumine) 0.1 mmol/kg by body weight, single IV injection Other Name: Magnevist

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

Ages Eligible for Study:	2 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01211873

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Locations

United States, Alabama

Birmingham, Alabama, United States
United States, Arizona

Tucson, Arizona, United States
United States, California

Indian Wells, California, United States
United States, Florida

Hollywood, Florida, United States
United States, Illinois

Chicago, Illinois, United States
United States, Kansas

Topeka, Kansas, United States
United States, Kentucky

Louisville, Kentucky, United States
United States, Massachusetts

Brookline, Massachusetts, United States
United States, Michigan

Ann Arbor, Michigan, United States

Farmington Hills, Michigan, United States
United States, North Carolina

Durham, North Carolina, United States
United States, Ohio

Cincinnati, Ohio, United States

Columbus, Ohio, United States
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States
United States, Texas

San Antonio, Texas, United States
UTHSCSA
San Antonio, Texas, United States
United States, Washington

Seattle, Washington, United States
United States, Wisconsin

Madison, Wisconsin, United States
Argentina

Buenos Aires, Argentina
Austria

Salzburg, Austria

Tulln, Austria

Vienna, Austria
Brazil

São Paulo, Brazil
Chile

Providencia, Chile

Santiago, Chile
France

Bordeaux, France

Lille, France

Montpellier, France

Paris, France

Poitiers, France

Rennes, France
Germany

Berlin, Germany

Frankfurt, Germany

Frankfurt/Main, Germany

Heidelberg, Germany

Leipzig, Germany

Mannheim, Germany

Munich, Germany
Italy

Firenze, Italy

Napoli, Italy

Roma, Italy
Korea, Republic of

Seoul, Korea, Republic of
Spain

Barcelona, Spain

Madrid, Spain

Vigo Pontevedra, Spain
United Kingdom

Cambridge, United Kingdom

Sponsors and Collaborators

Guerbet

More Information

No publications provided

Responsible Party:	Guerbet
ClinicalTrials.gov Identifier:	NCT01211873 History of Changes
Other Study ID Numbers:	DGD-44-050
Study First Received:	September 28, 2010
Last Updated:	January 30, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Guerbet:

CNS
Contrast Agent
MRI
Dotarem
Magnevist

Additional relevant MeSH terms:

Central Nervous System Diseases
Nervous System Diseases
Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate

Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013

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