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

NCT01211873 | Completed Phase 3 Results

• 1 other identifier: DGD-44-050
• Study Type: interventional
• Target: 416
• Locations: 11 countries
• Sites: 52

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.

Conditions

Diagnostic Self Evaluation; Central Nervous System Diseases

Keywords

CNS; Contrast Agent; MRI; Dotarem; Magnevist

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Image Quality Score

  up to 24 hours

• Diagnostic Confidence Score

  up to 24 hours

• Number of Lesions

  up to 24 hours

Study Arms (3)

Dotarem (gadoterate meglumine )

EXPERIMENTAL

Dotarem and Magnevist were randomised as 2:1 ratio for adult patients.

Drug: Dotarem (gadoterate meglumine)

Magnevist (gadopentetate dimeglumine)

ACTIVE COMPARATOR

Dotarem and Magnevist were randomised as 2:1 ratio

Drug: Magnevist (gadopentetate dimeglumine)

Dotarem 2 (gadoterate meglumine )

EXPERIMENTAL

Pediatric patients were assigned to Dotarem group only.

Drug: Dotarem (gadoterate meglumine)

Interventions

Dotarem (gadoterate meglumine) DRUG

0.1 mmol/kg by body weight, single IV injection

Also known as: Dotarem

Dotarem (gadoterate meglumine ); Dotarem 2 (gadoterate meglumine )

Magnevist (gadopentetate dimeglumine) DRUG

0.1 mmol/kg by body weight, single IV injection

Also known as: Magnevist

Magnevist (gadopentetate dimeglumine)

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guerbet: lead

Study Sites (52)

University of Alabama at Birmingham, UABMC

Birmingham, Alabama, 35233, United States

Location

University Medical Center

Tucson, Arizona, 47404, United States

Location

University medical center

Tucson, Arizona, 85724, United States

Location

Desert Medical Imaging

Indian Wells, California, 47404, United States

Location

Sunrise Clinical Research, Inc.

Hollywood, Florida, 33021, United States

Location

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Precise Clinical Research Solutions

Topeka, Kansas, 66604, United States

Location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Neurocare Center for Research

Brookline, Massachusetts, 02446, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

QUEST Research Institute

Farmington Hills, Michigan, 48334, United States

Location

Gruss Magnetic resonance Research Clinic

New York, New York, 10461, United States

Location

WestImage - Division of Research

Cincinnati, Ohio, 45248, United States

Location

Ohio State University

Columbus, Ohio, 47404, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Texas - Health Science Center

San Antonio, Texas, 47404, United States

Location

UTHSCSA

San Antonio, Texas, 47404, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Centro de Diagnóstico

Buenos Aires, Argentina

Location

Hospital Italiano

Buenos Aires, Argentina

Location

TCBA

Buenos Aires, Argentina

Location

Univ.-institut f.Radiodiagnostik

Salzburg, Austria

Location

Landesklinikum Tulln

Tulln, Austria

Location

Medical University of Vienna

Vienna, Austria

Location

Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, Brazil

Location

Universidade Federal de São Paulo / UNIFESP

São Paulo, Brazil

Location

Departamento de Neuroradiologia

Santiago, Chile

Location

Instituto de Neurocirugia Dr. Asenjo,

Santiago, Chile

Location

Hôpital Pellegrin

Bordeaux, France

Location

Hôpital Roger Salengro- CRHU de Lille

Lille, France

Location

Hôpital Gui De Chauliac

Montpellier, France

Location

Centre Hospitalier Sainte Anne

Paris, France

Location

Radiologie A - Hôpital de la Milétrie

Poitiers, France

Location

Fédération d'Imagerie Médicale,Hôpital Pontchaillou

Rennes, France

Location

University Hospital Charite

Berlin, Germany

Location

Krankenhaus Nordwest GmbH

Frankfurt, Germany

Location

University Hospital Frankfurt

Frankfurt am Main, Germany

Location

University of Heidelberg

Heidelberg, Germany

Location

University of Leipzig

Leipzig, Germany

Location

University Hospital Mannheim

Mannheim, Germany

Location

University Hospital LMU Munich

Munich, Germany

Location

Istituto di Radiologia

Florence, Italy

Location

Neuroradiologia,II Università Di Napoli

Napoli, Italy

Location

Azienda Ospedaliera S. Andrea

Roma, Italy

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National Unversity Hospital

Seoul, South Korea

Location

Hospital Vall d´Hebron

Barcelona, Spain

Location

Hospital Clinico Universitario San Carlos

Madrid, Spain

Location

Complejo Hospitalario Universitario de Vigo - Serviço de radiologia

Vigo, Spain

Location

University Department of Radiology

Cambridge, United Kingdom

Location

MeSH Terms

Conditions

Central Nervous System Diseases

Interventions

gadoterate meglumine; Gadolinium DTPA

Condition Hierarchy (Ancestors)

Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pentetic Acid; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Coordination Complexes

Results Point of Contact

• Title: Jing Hao, MD
• Organization: Guerbet

jing.hao@guerbet.com

+33145915000

Study Officials

• Ken Maravilla, MD

  University of Wasington School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: September 30, 2010
• Study Start: September 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: April 18, 2019
• Results First Posted: May 29, 2014

Record last verified: 2019-04

Locations

BR (2); ES (3); FR (6); DE (7); AU (3); CL (2); GB (1); KR (2); AR (3); IT (3); US (20)