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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01211873
Other study ID # DGD-44-050
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2010
Est. completion date November 2011

Study information

Verified date April 2019
Source Guerbet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called DotaremĀ®. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of DotaremĀ® 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 DotaremĀ®.


Recruitment information / eligibility

Status Completed
Enrollment 416
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender All
Age group 2 Years and older
Eligibility 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 Design


Intervention

Drug:
Dotarem (gadoterate meglumine)
0.1 mmol/kg by body weight, single IV injection
Magnevist (gadopentetate dimeglumine)
0.1 mmol/kg by body weight, single IV injection

Locations

Country Name City State
Argentina Centro de Diagnóstico Buenos Aires
Argentina Hospital Italiano Buenos Aires
Argentina TCBA Buenos Aires
Austria Univ.-institut f.Radiodiagnostik Salzburg
Austria Landesklinikum Tulln Tulln
Austria Medical University of Vienna Vienna
Brazil Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo São Paulo
Brazil Universidade Federal de São Paulo / UNIFESP São Paulo
Chile Departamento de Neuroradiologia Santiago
Chile Instituto de Neurocirugia Dr. Asenjo, Santiago
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
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
Italy Istituto di Radiologia Firenze
Italy Neuroradiologia,II Università Di Napoli Napoli
Italy Azienda Ospedaliera S. Andrea Roma
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National Unversity Hospital Seoul
Spain Hospital Vall d´Hebron Barcelona
Spain Hospital Clinico Universitario San Carlos Madrid
Spain Complejo Hospitalario Universitario de Vigo - Serviço de radiologia Vigo
United Kingdom University Department of Radiology Cambridge
United States University of Michigan Ann Arbor Michigan
United States University of Alabama at Birmingham, UABMC Birmingham Alabama
United States Neurocare Center for Research Brookline Massachusetts
United States Medical University of South Carolina Charleston South Carolina
United States Children's Memorial Hospital Chicago Illinois
United States WestImage - Division of Research Cincinnati Ohio
United States Ohio State University Columbus Ohio
United States QUEST Research Institute Farmington Hills Michigan
United States Sunrise Clinical Research, Inc. Hollywood Florida
United States Desert Medical Imaging Indian Wells California
United States University of Louisville Hospital Louisville Kentucky
United States University of Wisconsin Hospital and Clinics Madison Wisconsin
United States Gruss Magnetic resonance Research Clinic New York New York
United States Clinical Trials of Texas, Inc. San Antonio Texas
United States University of Texas - Health Science Center San Antonio Texas
United States UTHSCSA San Antonio Texas
United States University of Washington Medical Center Seattle Washington
United States Precise Clinical Research Solutions Topeka Kansas
United States University Medical Center Tucson Arizona
United States University medical center Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
Guerbet

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Brazil,  Chile,  France,  Germany,  Italy,  Korea, Republic of,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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