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

Safety and Efficacy Evaluation of DOTAREM® in Magnetic Resonance Imaging (MRI) in Patients With Central Nervous System (CNS) Lesions.

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.

Study Overview

• Status: Completed
• Conditions: Central Nervous System Diseases; Diagnostic Self Evaluation
• Intervention / Treatment: Drug: Dotarem (gadoterate meglumine); Drug: Magnevist (gadopentetate dimeglumine)

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 Type: Interventional
• Enrollment (Actual): 416
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Hospital Italiano
  • Buenos Aires, Argentina
    • Centro de Diagnóstico
  • Buenos Aires, Argentina
    • TCBA
• Austria
  • Salzburg, Austria
    • Univ.-institut f.Radiodiagnostik
  • Tulln, Austria
    • Landesklinikum Tulln
  • Vienna, Austria
    • Medical University of Vienna
• Brazil
  • São Paulo, Brazil
    • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
  • São Paulo, Brazil
    • Universidade Federal de São Paulo / UNIFESP
• Chile
  • Santiago, Chile
    • Departamento de Neuroradiologia
  • Santiago, Chile
    • Instituto de Neurocirugia Dr. Asenjo,
• France
  • Bordeaux, France
    • Hôpital Pellegrin
  • Lille, France
    • Hôpital Roger Salengro- CRHU de Lille
  • Montpellier, France
    • Hopital Gui de Chauliac
  • Paris, France
    • Centre Hospitalier Sainte Anne
  • Poitiers, France
    • Radiologie A - Hôpital de la Milétrie
  • Rennes, France
    • Fédération d'Imagerie Médicale,Hôpital Pontchaillou
• Germany
  • Berlin, Germany
    • University Hospital Charité
  • Frankfurt, Germany
    • Krankenhaus Nordwest GmbH
  • Frankfurt/Main, Germany
    • University Hospital Frankfurt
  • Heidelberg, Germany
    • University of Heidelberg
  • Leipzig, Germany
    • University of Leipzig
  • Mannheim, Germany
    • University Hospital Mannheim
  • Munich, Germany
    • University Hospital LMU Munich
• Italy
  • Firenze, Italy
    • Istituto di Radiologia
  • Napoli, Italy
    • Neuroradiologia,II Università Di Napoli
  • Roma, Italy
    • Azienda OSpedaliera S. Andrea
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Seoul National Unversity Hospital
• Spain
  • Barcelona, Spain
    • Hospital Vall D´Hebron
  • Madrid, Spain
    • Hospital Clinico Universitario San Carlos
  • Vigo, Spain
    • Complejo Hospitalario Universitario de Vigo - Serviço de radiologia
• United Kingdom
  • Cambridge, United Kingdom
    • University Department of Radiology
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham, UABMC
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University Medical Center
    • Tucson, Arizona, United States, 47404
      • University Medical Center
  • California
    • Indian Wells, California, United States, 47404
      • Desert Medical Imaging
  • Florida
    • Hollywood, Florida, United States, 33021
      • Sunrise Clinical Research, Inc.
  • Illinois
    • Chicago, Illinois, United States, 60614
      • Children's Memorial Hospital
  • Kansas
    • Topeka, Kansas, United States, 66604
      • Precise Clinical Research Solutions
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Hospital
  • Massachusetts
    • Brookline, Massachusetts, United States, 02446
      • Neurocare Center for Research
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Quest Research Institute
  • New York
    • New York, New York, United States, 10461
      • Gruss Magnetic resonance Research Clinic
  • Ohio
    • Cincinnati, Ohio, United States, 45248
      • WestImage - Division of Research
    • Columbus, Ohio, United States, 47404
      • Ohio State University
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
    • San Antonio, Texas, United States, 47404
      • University of Texas - Health Science Center
    • San Antonio, Texas, United States, 47404
      • UTHSCSA
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: Dotarem

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both "Pre" and "Paired" Evaluation	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.	up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Image Quality Score	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.	up to 24 hours
Diagnostic Confidence Score	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).	up to 24 hours
Number of Lesions	The number of lesions for which observations could be made was calculated for each MRI modality and results are summarized per patient	up to 24 hours

Collaborators and Investigators

• Sponsor: Guerbet
• Investigators: Principal Investigator: Ken Maravilla, MD, University of Wasington School of Medicine

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ACTUAL): November 1, 2011

Study Registration Dates

• First Submitted: September 28, 2010
• First Submitted That Met QC Criteria: September 29, 2010
• First Posted (ESTIMATE): September 30, 2010

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 4, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: MRI; CNS; Magnevist; Contrast Agent; Dotarem
• Additional Relevant MeSH Terms: Nervous System Diseases; Central Nervous System Diseases; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
• Other Study ID Numbers: DGD-44-050