Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04776187
Status:
UNKNOWN
Last Update Posted:
2021-03-01
First Post:
2021-01-11
Brief Title:
Safety Evaluation of Linear and Macrocyclic Gadolinium Based Contrast Agents for Patients With Mild to Moderate Renal Insufficiency Undergoing Enhanced Magnetic Resonance Imaging
Sponsor:
The Central Hospital of Lishui City
Organization:
The Central Hospital of Lishui City
Study Overview
Official Title:
Safety Evaluation of Linear and Macrocyclic Gadolinium-Based Contrast Agents for Patients With Mild to Moderate Renal Insufficiency Undergoing Enhanced Magnetic Resonance Imaging Interventional Prospective Study Clinical Trial Protocol
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety of linear and macrocyclic gadolinium-based contrast agents for patients with mild to moderate renal insufficiency The study will compare the incidence of adverse events of gadodiamide and gadoteric Acid Meglumine Salt for patients with mild to moderate renal insufficiency undergoing enhanced magnetic resonance imaging
Detailed Description:
According to the requirements of the study 600 cases of patients with mild to moderate renal insufficiency were enrolled Gadodiamide and Gadoteric acid meglumine salt were used for enhanced MRI Observe the adverse reactions within 60 minutes of using the gadolinium contrast agents follow up by telephone at 3 6 12 and 24 months after the inspection The primary endpoint is the incidence of the various adverse events and the secondary endpoints are changes of serum creatinine and inflammatory factors TNF-α hs-CRP IL-6 before and after CE-MRI patient skin examination and evaluation evaluation of relevant indicators of skin biopsy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None