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

Guerbet

Status and phase: Completed; Phase 3

Conditions: Diagnostic Self Evaluation; Central Nervous System Diseases

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01211873

DGD-44-050

Details and patient eligibility

About

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.

Full 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®.

Enrollment: 416 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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416 participants in 3 patient groups

Dotarem (gadoterate meglumine )

Experimental group

Description:

Dotarem and Magnevist were randomised as 2:1 ratio for adult patients.

Treatment:

Drug: Dotarem (gadoterate meglumine)

Magnevist (gadopentetate dimeglumine)

Active Comparator group

Description:

Dotarem and Magnevist were randomised as 2:1 ratio

Treatment:

Drug: Magnevist (gadopentetate dimeglumine)

Dotarem 2 (gadoterate meglumine )

Experimental group

Description:

Pediatric patients were assigned to Dotarem group only.

Treatment:

Drug: Dotarem (gadoterate meglumine)