Multicenter evaluation of the safety, tolerance, and efficacy of OptiMARK in magnetic resonance imaging of the brain and spine

This was a multicenter, crossover, double-blind study. Patients with known or suspected pathology and/or structural abnormality of the brain or spine were recruited from multiple study centers and randomized to receive two unique doses of OptiMARK. There were three possible pairs of doses for administration: 0.1 and 0.3 mmol/kg, 0.1 and 0.5 mmol/kg, and 0.3 and 0.5 mmol/kg. A minimum of 24 hours was allowed between doses for adequate washout of OptiMARK. Both doses Were administered within a 7-day period, and patients were not allowed to undergo intervention that would alter the pathologic process