Magnetic resonance imaging (MRI) is a powerful tool for the diagnosis of a broad range of clinical conditions. Expensive contrast media (about $110.00/dose) contribute to its high cost. The goal of this SBIR grant is to perform the preliminary steps necessary for a pre-IND evaluation by the FDA of a new inexpensive agent, Gadolinium DTPA Bisglucosamide. Preliminary investigations show lower animal toxicity, improved gadolinium chelate stability and zinc transmetalation kinetics compared to several currently approved agents. It demonstrates a two-fold improvement in liver and renal enhancement compared with current extracellular MRI contrast agents. These attributes create significant potential for the commercialization of this agent. Magnetic Research, Inc. intends to: * Perfect and document the synthesis and purification of Gd DTPA bis- glucosamide. * Develop a source for bulk manufacture. * Perform pre-IND FDA documentation including minimum lethal dosage testing in animals. * Determine chemical properties (osmolality, viscosity, density). * Validate transmetalation kinetics and thermodynamic stabilities. * Perform shelf life stability and sterilization experiments. * Initiate the selection of human evaluation sites. Purification and analysis will be performed with high field NMR, supercritical flow chromatography, and high resolution CC-MS, and HPLC with fluorescence detection. Dr. Gary Booth, Brigham Young University, will perform animal minimum lethal dosage tests.
| Puttagunta, N R; Gibby, W A; Puttagunta, V L (1996) Comparative transmetallation kinetics and thermodynamic stability of gadolinium-DTPA bis-glucosamide and other magnetic resonance imaging contrast media. Invest Radiol 31:619-24 |
