PHARMACOLOGY OF OPTIMARK IN PATIENTS WITH CNS OR LIVER PATHOLOGY

OPTIMARK 在中枢神经系统或肝脏病变患者中的药理学

• 批准号: 6121111
• 负责人: BRUCE J BARRON
• 金额: $ 1.51万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6121111
• 关键词: chelating agents; clinical research; clinical trial phase I; contrast media; dosage; drug adverse effect; drug screening /evaluation; gadolinium; human subject; liver disorder; magnetic resonance imaging; neuropathology; pharmacology

The primary aim of this Phase I study is to evaluate the pharmacological dose-related effects of a newly developed contrast agent for use with MRI. Agents currently being used are available in doses of 0.1 to 0.3 mmol/kg. This new agent is a non-ionic, extracellular, linear gadolinium based chelate that will be tested in doses of 0.1, 0.3, and 0.5 mmol/kg. Subjects will be patients with known brain, spine, and/or liver disease, and were chosen to be representative of the type of patient for which contrast MRI is currently being used. This study was completed in September, 1997.

本I期研究的主要目的是评价 新开发的MRI造影剂的剂量相关效应。 目前使用的药物剂量为0.1至0.3 mmol/kg。 这种新的代理商是一种非离子，细胞外，线性钆基 将以0.1、0.3和0.5 mmol/kg的剂量测试螯合物。 受试者将是已知患有脑部、脊柱和/或肝脏疾病的患者， 并被选为代表患者类型， 目前正在使用对比MRI。 这项研究于1997年9月完成。