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

Central Nervous System Diseases Clinical Trial

— SENTIO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01211873
• Other study ID #: DGD-44-050
• Status: Completed
• Phase: Phase 3
• Start date: September 2010
• Est. completion date: November 2011

Study information

• Verified date: April 2019
• Source: Guerbet
• Contact: n/a
• Is FDA regulated: No
• 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 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®.

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.

Related Conditions & MeSH terms

• Central Nervous System Diseases
• Diagnostic Self Evaluation
• Nervous System Diseases

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