Gadolinium zeolite as an oral contrast agent for magnetic resonance imaging

The purpose of thls study was to evaluate efficacy and safety of a gadolinium (Gd) zeolite suspension aa an oral MRI contrast agent. Serial dilution of GADO‐ LITE@ orpl Suspdon 1.2500 pg of GdO/mL) were prepared. MRI (T1 and T2 welghted) of standards and dogs (precontrast and postcontraat) were performed. Toxicity and Gd absorption were also asmaued. Subsequently, 30 nod male adult volunteers were divided into six group of five subjects each. Gd zeolite po suspension waa adminlstered before and after MRI in volumes and concentrations ranging from 250 to 1600 mL; 6 to 80 pg of Gd+3/mL. The images were rated (efficacy score) by a bllnded reader. Vital signs, blood chemistries and urlnalysia were recorded. Gadollte Oral Suspension produced excellent enhancement of the dog gastrointestinal (GI) tract. No todclty or absorption of Gd wan obsenred in dogs receiving doses up to 4 times the anticipated human dose My for 14 consecutive days. In clinical tri.lr. Gd zeollte slgnlficantly lmproved the efficacy scores for all groups and all pulrina sequences (all P values