SAFETY AND EFFICACY EVALUATION OF DOTAREM® IN MAGNETIC RESONANCE IMAGING (MRI) IN PATIENTS WITH CENTRAL NERVOUS SYSTEM (CNS) LESIONS (SENTIO Study) - SAFETY AND EFFICACY EVALUATION OF DOTAREM IN MRI OF CNS LESIONS

• Register: EUCTR
• Last refreshed on: 11 September 2012
• Main ID: EUCTR2010-020319-34-GB
• Date of registration: 08/10/2010
• Prospective Registration: Yes
• Primary sponsor: Guerbet Laboratories Ltd.
• Public title: SAFETY AND EFFICACY EVALUATION OF DOTAREM® IN MAGNETIC RESONANCE IMAGING (MRI) IN PATIENTS WITH CENTRAL NERVOUS SYSTEM (CNS) LESIONS (SENTIO Study) - SAFETY AND EFFICACY EVALUATION OF DOTAREM IN MRI OF CNS LESIONS
• Scientific title: SAFETY AND EFFICACY EVALUATION OF DOTAREM® IN MAGNETIC RESONANCE IMAGING (MRI) IN PATIENTS WITH CENTRAL NERVOUS SYSTEM (CNS) LESIONS (SENTIO Study) - SAFETY AND EFFICACY EVALUATION OF DOTAREM IN MRI OF CNS LESIONS
• Date of first enrolment: 24/12/2010
• Target sample size: 396
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020319-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Multicentre, randomized, double-blind, fixed-sequence, comparative If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Other specify the comparator: Marketed medicinal product (Magnevist)

Countries of recruitment

Austria, Germany, Italy, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
• Adult subject, and pediatric subjects (from aged 2 years) who will be enrolled only in Latin America and/or in the USA.
• Having been referred for a contrast-enhanced MRI of the CNS based on the results of a previous imaging procedure
• Female patients of childbearing potential 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.
• Having consented to participate after being fully informed about the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 having been 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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Central nervous (CNS) lesions (brain and spine lesions)
MedDRA version: 12.1 Level: SOC Classification code 10029205 Term: NERVOUS SYSTEM DISORDERS

Intervention(s)

Trade Name: DOTAREM
Product Name: Dotarem
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: gadoterate meglumine
Concentration unit: mmol/kg millimole(s)/kilogram

Trade Name: MAGNEVIST
Product Name: Magnevist
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Gadopentetate dimeglumine

Primary Outcome(s)

Primary end point(s): The three co-primary criteria in terms of lesion visualizations (lesion border delineation, lesion internal morphology and lesion contrast enhancement) will be assessed for the five largest representative lesions detected according to the 3-point scales: 0 = Unevaluable/1 = Seen, but imperfectly/2 = Seen completely/perfectly
From each of co-primary endpoints, a patient score will be calculated by adding up all lesion scores within subject. The subject primary assessment will consist of 3 separate scores.
The primary outcomes will be assessed by off-site readers. The acceptable criterion for the study is that 2 out of 3 readers simultaneously meet the co-primary endpoints.

Secondary Objective: • Compare Dotarem-enhanced MRI to Magnevist-enhanced MRI for: lesion visualization, the quality of images, the level of diagnostic confidence, the signal intensity, number and location of the lesions.
• Demonstrate superiority of Dotarem-enhanced MRI to unenhanced MRI for the level of diagnostic confidence, the quality of images, the level of diagnostic confidence, the signal intensity, number and location of the lesions.
• Assess the safety profile of Dotarem compared to Magnevist.
• Assess the safety and efficacy of Dotarem in pediatric population.

Main Objective: To document the superiority of Dotarem as a contrast agent over non contrast enhanced MRI for the evaluation of CNS lesions (brain and spine lesions), and the primary objective is in terms of lesion visualization.

Secondary ID(s)

2010-020319-34-DE

N/A

DGD-44-050