We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01211873
Recruitment Status : Completed
First Posted : September 30, 2010
Results First Posted : May 29, 2014
Last Update Posted : May 19, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Diagnostic Self Evaluation Central Nervous System Diseases Drug: Dotarem (gadoterate meglumine) Drug: Magnevist (gadopentetate dimeglumine) Phase 3

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®.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 416 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : September 2010
Primary Completion Date : November 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Dotarem (gadoterate meglumine )
Dotarem and Magnevist were randomised as 2:1 ratio for adult patients.
Drug: Dotarem (gadoterate meglumine)
0.1 mmol/kg by body weight, single IV injection
Other Name: Dotarem
Active Comparator: Magnevist (gadopentetate dimeglumine)
Dotarem and Magnevist were randomised as 2:1 ratio
Drug: Magnevist (gadopentetate dimeglumine)
0.1 mmol/kg by body weight, single IV injection
Other Name: Magnevist
Experimental: Dotarem 2 (gadoterate meglumine )
Pediatric patients were assigned to Dotarem group only.
Drug: Dotarem (gadoterate meglumine)
0.1 mmol/kg by body weight, single IV injection
Other Name: Dotarem

Outcome Measures

Primary Outcome Measures :
  1. MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both "Pre" and "Paired" Evaluation, Each Lesion is Scored With 3-point Scales. [ Time Frame: up to 24 hours as the safety is assessed till 24 hours after injection ]

    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 :
  1. The Quality of Images on 3-point Scale: Poor, Fair or Good. [ Time Frame: up to 24 hours as the safety is assessed till 24 hours after injection ]
  2. 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 as the safety is assessed till 24 hours after injection ]
  3. Number of Lesions With MRI Signal Intensity Changes After Contrast Agent Injection. [ Time Frame: up to 24 hours as the safety is assessed till 24 hours after injection ]
  4. Number of Participants With Adverse Events as a Measure of Safety and Tolerability. [ Time Frame: up to 29 days ]
  5. Measure Vital Signs (Supine Systolic and Diastolic Blood Pressures, Pulse). [ Time Frame: up to 24 hours ]
  6. Measure ECG [ Time Frame: up to 24 hours ]
  7. Injection-site Tolerance on the Visual Analog Scale From 0 (no Pain) to 10 (Maximal Pain). [ Time Frame: up to 24 hours ]
  8. Measure Blood Sample. [ Time Frame: up to 24 hours ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01211873

  Hide Study Locations
United States, Alabama
University of Alabama at Birmingham, UABMC
Birmingham, Alabama, United States, 35233
United States, Arizona
University Medical Center
Tucson, Arizona, United States, 47404
University medical center
Tucson, Arizona, United States, 85724
United States, California
Desert Medical Imaging
Indian Wells, California, United States, 47404
United States, Florida
Sunrise Clinical Research, Inc.
Hollywood, Florida, United States, 33021
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Kansas
Precise Clinical Research Solutions
Topeka, Kansas, United States, 66604
United States, Kentucky
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Neurocare Center for Research
Brookline, Massachusetts, United States, 02446
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
QUEST Research Institute
Farmington Hills, Michigan, United States, 48334
United States, New York
Gruss Magnetic resonance Research Clinic
NYC, New York, United States, 10461
United States, Ohio
WestImage - Division of Research
Cincinnati, Ohio, United States, 45248
Ohio State University
Columbus, Ohio, United States, 47404
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
University of Texas - Health Science Center
San Antonio, Texas, United States, 47404
San Antonio, Texas, United States, 47404
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Centro de Diagnóstico
Buenos Aires, Argentina
Hospital Italiano
Buenos Aires, Argentina
Buenos Aires, Argentina
Univ.-institut f.Radiodiagnostik
Salzburg, Austria
Landesklinikum Tulln
Tulln, Austria
Medical University of Vienna
Vienna, Austria
Hospital das Clínicas 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
Korea, Republic of
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
United Kingdom
University Department of Radiology
Cambridge, United Kingdom
Sponsors and Collaborators
Principal Investigator: Ken Maravilla, MD University of Wasington School of Medicine
More Information

Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT01211873     History of Changes
Other Study ID Numbers: DGD-44-050
First Posted: September 30, 2010    Key Record Dates
Results First Posted: May 29, 2014
Last Update Posted: May 19, 2016
Last Verified: April 2016

Keywords provided by Guerbet:
Contrast Agent

Additional relevant MeSH terms:
Nervous System Diseases
Central Nervous System Diseases
Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action