SAFETY AND EFFICACY EVALUATION OF DOTAREM IN MRI OF CNS LESIONS

• Research type

  Research Study

• Full title

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

• IRAS ID

  59677

• Contact name

  Jonathan Harvey Gillard

• Sponsor organisation

  Guerbet Laboratories Ltd.

• Eudract number

  2010-020319-34

• ISRCTN Number

  N/A

• Research summary

  Dotarem© is a well established macrocyclic MRI contrast agent already licensed for general use in more than 60 countries. However, Dotarem© has not yet been marketed in the United States. This Phase III pivotal study is part of the clinical development plan to demonstrate continued safety and efficacy of Dotarem© and to support a New Drug Application (NDA) in the United States. The purpose of this study is 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). Participation in this study will involve 3 study visits. Depending on how long it is between screening assessment and when study MRI examination scheduled, the maximum time for participation in this trial is 29 days (for example, screening 28 days prior to MRI, the day of MRI examination, safety follow-up the day after). The minimum time would be 2 days (screening and study MRI performed on the same day, safety follow-up the day after). This study is a multicenter, double-blind, randomized, parallel assignment, comparative study. The study will be carried out at approximately 55 centers in the USA, Latin America, Europe and South Korea. Approximately 396 patients will be enrolled in this study.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  10/H0304/84

• Date of REC Opinion

  24 Dec 2010

• REC opinion

  Further Information Favourable Opinion