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

Information source: Guerbet
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diagnostic Self Evaluation; Central Nervous System Diseases

Intervention: Dotarem (gadoterate meglumine) (Drug); Magnevist (gadopentetate dimeglumine) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Guerbet

Official(s) and/or principal investigator(s):
Ken Maravilla, MD, Principal Investigator, Affiliation: University of Wasington School of Medicine

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Primary outcome: 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.

Secondary outcome:

The Quality of Images on 3-point Scale: Poor, Fair or Good.

Level of Diagnostic Confidence on 5-point Scale Ranging From Nil to Excellent With Poor, Moderate and High as Intermediate Grades.

Number of Lesions With MRI Signal Intensity Changes After Contrast Agent Injection.

Number of Participants With Adverse Events as a Measure of Safety and Tolerability.

Measure Vital Signs (Supine Systolic and Diastolic Blood Pressures, Pulse).

Measure ECG

Injection-site Tolerance on the Visual Analog Scale From 0 (no Pain) to 10 (Maximal Pain).

Measure Blood Sample.

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

Minimum age: 2 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Centro de Diagnóstico, Buenos Aires, Argentina

Hospital Italiano, Buenos Aires, Argentina

TCBA, 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

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

University Department of Radiology, Cambridge, United Kingdom

University of Alabama at Birmingham, UABMC, Birmingham, Alabama 35233, United States

University Medical Center, Tucson, Arizona 47404, United States

University medical center, Tucson, Arizona 85724, United States

Desert Medical Imaging, Indian Wells, California 47404, United States

Sunrise Clinical Research, Inc., Hollywood, Florida 33021, United States

Children's Memorial Hospital, Chicago, Illinois 60614, United States

Precise Clinical Research Solutions, Topeka, Kansas 66604, United States

University of Louisville Hospital, Louisville, Kentucky 40202, United States

Neurocare Center for Research, Brookline, Massachusetts 02446, United States

University of Michigan, Ann Arbor, Michigan 48109, United States

QUEST Research Institute, Farmington Hills, Michigan 48334, United States

Gruss Magnetic resonance Research Clinic, NYC, New York 10461, United States

WestImage - Division of Research, Cincinnati, Ohio 45248, United States

Ohio State University, Columbus, Ohio 47404, United States

Medical University of South Carolina, Charleston, South Carolina 29425, United States

Clinical Trials of Texas, Inc., San Antonio, Texas 78229, United States

University of Texas - Health Science Center, San Antonio, Texas 47404, United States

UTHSCSA, San Antonio, Texas 47404, United States

University of Washington Medical Center, Seattle, Washington 98195, United States

University of Wisconsin Hospital and Clinics, Madison, Wisconsin 53792, United States

Additional Information

Starting date: September 2010
Last updated: April 29, 2014

Page last updated: August 23, 2015

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