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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guerbet
ClinicalTrials.gov Identifier:
NCT01211873
First received: September 28, 2010
Last updated: April 29, 2014
Last verified: April 2014
  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 Self Evaluation
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:


Further study details as provided by Guerbet:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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. At patient level, the maximum score is 10, minimum score is 0.



Secondary Outcome Measures:
  • 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 ] [ 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 as the safety is assessed till 24 hours after injection ] [ Designated as safety issue: No ]
  • 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 ] [ 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 )
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

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
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, see Learn About Clinical Studies.

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

  Hide Study Locations
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
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
University of Texas - Health Science Center
San Antonio, Texas, United States, 47404
UTHSCSA
San Antonio, Texas, United States, 47404
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
Argentina
Centro de Diagnóstico
Buenos Aires, Argentina
Hospital Italiano
Buenos Aires, Argentina
TCBA
Buenos Aires, Argentina
Austria
Univ.-institut f.Radiodiagnostik
Salzburg, Austria
Landesklinikum Tulln
Tulln, Austria
Medical University of Vienna
Vienna, Austria
Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, Brazil
Universidade Federal de São Paulo / UNIFESP
São Paulo, Brazil
Chile
Departamento de Neuroradiologia
Santiago, Chile
Instituto de Neurocirugia Dr. Asenjo,
Santiago, Chile
France
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
Germany
University Hospital Charite
Berlin, Germany
Krankenhaus Nordwest GmbH
Frankfurt, Germany
University Hospital Frankfurt
Frankfurt/Main, Germany
University of Heidelberg
Heidelberg, Germany
University of Leipzig
Leipzig, Germany
University Hospital Mannheim
Mannheim, Germany
University Hospital LMU Munich
Munich, Germany
Italy
Istituto di Radiologia
Firenze, Italy
Neuroradiologia,II Università Di Napoli
Napoli, Italy
Azienda Ospedaliera S. Andrea
Roma, Italy
Korea, Republic of
Seoul National Unversity Hospital
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Spain
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
Guerbet
Investigators
Principal Investigator: Ken Maravilla, MD University of Wasington School of Medicine
  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
Results First Received: July 25, 2013
Last Updated: April 29, 2014
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
Gadobenic acid
Gadolinium DTPA
Gadoterate meglumine
Meglumine
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 21, 2014