EVP-ABD Enhanced MRI for Evaluation Liver Disease

描述（由申请人提供）：项目摘要/摘要：病毒感染和化学，药物或酒精中毒引起的肝炎正在给医疗保健系统带来越来越大的负担。肝炎的初步诊断可能依赖于病史、肝功能检查（LFT）、聚合酶链反应（PCR）结果等;肝炎的确认、表征（分级和分期）和随访依赖于作为金标准的肝活检，尽管与该过程相关的发病率显著且死亡风险小但明确。一种非侵入性的检测方法可以提供弥漫性肝病性质和程度的可靠测量，与组织学相关，从而减少对定期活检的依赖，这将满足一个主要的未满足的需求。Eagle Vision Pharmaceutical Corp（EAGLE）正在开发EVP-ABD，这是一种基于细胞内锰的磁共振成像（MRI）造影剂，具有独特的磁性和动力学特性。本研究将评价EVP-ABD的能量依赖性细胞内摄取（通过MRI成像非侵入性评估）和肝功能（通过组织学评估）之间的相关性。项目叙述：该研究的长期目标是在美国和其他地方注册和商业化EVP-ABD，作为诊断、表征和评估弥漫性肝病治疗有效性的造影剂。如果成功的话，EVP-ABD应该通过提供弥漫性肝病的非侵入性评估来减少对连续肝活检的依赖，从而降低与该手术相关的发病率。

DESCRIPTION (provided by applicant): Project Summary/Abstract: Hepatitis deriving from viral infection and chemical, drug or alcohol toxicity is placing a growing burden on the health care system. While initial diagnosis of hepatitis may rely on medical history, Liver Function Tests (LFT), Polymerase Chain Reaction (PCR) results, etc.; confirmation, characterization (grading and staging) and follow-up of hepatitis relies on liver biopsy as the gold standard despite significant morbidity and a small but definite risk of mortality associated with the procedure. A non-invasive test that would provide a reliable measure of the nature and magnitude of diffuse liver disease, correlating to histology and thereby reducing the dependence on periodic biopsies would meet a major unmet need. Eagle Vision Pharmaceutical Corp (EAGLE) is developing EVP-ABD, an intracellular manganese based Magnetic Resonance Imaging (MRI) contrast agent, with unique magnetic and kinetic properties. The potential for correlation between the energy dependent intracellular uptake of EVP-ABD (assessed noninvasively by MRI imaging) and liver function (assessed by histology) will be evaluated in this study. Project Narrative: The long term goal of the research is to register and commercialize EVP-ABD in the US and elsewhere as a contrast agent for diagnosis, characterization and assessing effectiveness of treatment of diffuse liver disease. If successful, EVP-ABD should reduce the dependence on serial liver biopsies by providing a noninvasive assessment of diffuse liver disease, and thus reduce the morbidity associated with the procedure.