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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01211873
• Date of registration: 28/09/2010
• Primary sponsor: Guerbet
• Public title: Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions SENTIO
• Scientific title: Safety and Efficacy Evaluation of DOTAREM® in Magnetic Resonance Imaging (MRI) in Patients With Central Nervous System (CNS) Lesions.
• Date of first enrolment: September 2010
• Target sample size: 416
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01211873
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Countries of recruitment

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

Key inclusion & exclusion criteria

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.



Age minimum: 2 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Central Nervous System Diseases

Diagnostic Imaging

Intervention(s)

Drug: Dotarem (gadoterate meglumine)

Drug: Magnevist (gadopentetate dimeglumine)

Primary Outcome(s)

MRI lesion visualization with 3 parameters (lesion border delineation, internal morphology and degree of contrast enhancement) on 3-point scales. [Time Frame: up to 24 hours]

Secondary Outcome(s)

Injection-site tolerance on the Visual Analog Scale from 0 (no pain) to 10 (maximal pain). [Time Frame: up to 24 hours]

Level of diagnostic confidence on 5-point scale ranging from nil to excellent with poor, moderate and high as intermediate grades. [Time Frame: up to 24 hours]

Measure blood sample. [Time Frame: up to 24 hours]

Measure ECG [Time Frame: up to 24 hours]

Measure vital signs (supine systolic and diastolic blood pressures, pulse). [Time Frame: up to 24 hours]

Number of lesions with MRI signal intensity changes after contrast agent injection. [Time Frame: up to 24 hours]

Number of participants with Adverse Events as a measure of safety and tolerability. [Time Frame: up to 29 days]

The quality of images on 3-point scale: poor, fair or good. [Time Frame: up to 24 hours]

Secondary ID(s)

DGD-44-050

Source(s) of Monetary Support

Please refer to primary and secondary sponsors