Central Nervous System Diseases Clinical Trial
— SENTIOOfficial title:
Safety and Efficacy Evaluation of DOTAREM® in Magnetic Resonance Imaging (MRI) in Patients With Central Nervous System (CNS) Lesions.
Verified date | April 2019 |
Source | Guerbet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Guerbet |
United States, Argentina, Austria, Brazil, Chile, France, Germany, Italy, Korea, Republic of, Spain, United Kingdom,
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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