Last updated on November 2018

P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)


Brief description of study

The purpose of this study is to determine an effective and safe clinical dose of a new gadolinium-based contrast agent (GBCA) P03277 injection for Central Nervous System (CNS) lesion detection and visualization by conventional steady-state CNS imaging. Therefore, Contrast to Noise Ratio (CNR), a well-known quantitative parameter directly related to contrast medium/GBCA efficacy, has been chosen as the primary endpoint in order to have a precise determination of P03277 clinical dose.

This is a multi-center, international, prospective, double-blind, randomized, controlled, parallel dose groups, cross-over with comparator study in male and female subjects presenting with either known or highly suspected focal areas of disruption of the Blood Brain Barrier (BBB) (e.g. primary and secondary tumors, focal inflammatory or demyelination disorders), who are scheduled to undergo a routine contrast-enhanced Magnetic Resonance Imaging (MRI) of the CNS.

This study will be conducted in approximately 40 centers worldwide.

Two subsets of subjects will be included in the study:

  • The first subset will include the first subject of each study center. Subjects will be administered at 0.05 or 0.1 mmol/kg body weight (BW) of P03277 and MultiHance, 0.1 mmol/kg BW.
  • The second subset will comprise all other subjects selected by the sites. Subjects will be administered at 0.025, 0.05, 0.1, 0.2 mmol/kg BW of P03277 and 0.1 mmol/kg BW of MultiHance.

During the course of the study, two MRIs will be obtained from each subject: one unenhanced and P03277-enhanced MRI; and one unenhanced and MultiHance-enhanced MRI. MRI evaluations will be performed by on-site investigators and three independent off-site blinded readers.

Detailed Study Description

The purpose of this study is to determine an effective and safe clinical dose of a new gadolinium-based contrast agent (GBCA) P03277 injection for Central Nervous System (CNS) lesion detection and visualization by conventional steady-state CNS imaging. Therefore, Contrast to Noise Ratio (CNR), a well-known quantitative parameter directly related to contrast medium/GBCA efficacy, has been chosen as the primary endpoint in order to have a precise determination of P03277 clinical dose.

Clinical Study Identifier: NCT02633501

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Martin BENDSZUS, Prof. Dr. med.

Althian Research Management Center
Monterrey Nuevo Leon, Mexico