the Accuracy and Safety of Renal Artery Contrast-enhanced Magnetic Resonance Imaging With Polysaccharide Superparamagnetic Iron Oxide Nanoparticle

• Status: Not yet recruiting
• Trial end date: 2022-09-30

Summary

This study is a single-center, prospective, controlled and diagnostic clinical trial to explore the effectiveness and safety of domestic polysaccharide superparamagnetic iron oxide injection for contrast-enhanced renal artery magnetic resonance. This study will enroll 40 patients scheduled for renal arteriography in China.The investigators will record the baseline data of patients after admission.Patients will receive contrast-enhanced renal artery magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle to assess renal artery stenosis.The related laboratory indexes will be reviewed at 72 h after Magnetic Resonance Imaging ,and then patients will receive renal angiography . The indexes were reexamined at 1 month and 3 months after magnetic resonance imaging. The investigators will Record all clinical adverse events. In order to evaluate the safety of polysaccharide superparamagnetic iron oxide nanoparticle, patients will detect iron levels in peripheral and tissue before and after the examination.The investigators will Record all clinical adverse events in this study.

• Phase: Phase 1

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborators: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; School of Biological Science and Medical Engineering, Southeast University; School of Biomedical Engineering and Information, Nanjing Medical University