Last reviewed · How we verify
Safety and Efficacy Evaluation of DOTAREM® in Magnetic Resonance Imaging (MRI) in Patients With Central Nervous System (CNS) Lesions. (SENTIO)
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.
Details
| Lead sponsor | Guerbet |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 416 |
| Start date | 2010-09 |
| Completion | 2011-11 |
Conditions
- Diagnostic Self Evaluation
- Central Nervous System Diseases
Interventions
- Dotarem (gadoterate meglumine)
- Magnevist (gadopentetate dimeglumine)
Primary outcomes
- MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both "Pre" and "Paired" Evaluation — up to 24 hours
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.
Countries
United States, Argentina, Austria, Brazil, Chile, France, Germany, Italy, South Korea, Spain, United Kingdom