Active Surveillance of the Safety of Gadolinium-based Contrast Agent(s) in India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of adverse events reported after use of branded gadolinium-based contrast agent (GBCA).
研究概览
简要总结
This is an observational study in which data from patients undergoing enhanced MRI using gadolinium based agents (GBCAs) are collected and studied.
An MRI is a test that uses strong magnets and radio waves to make detailed pictures of the inside of the body. The contrast agents commonly used in MRI are gadolinium based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd), which helps to increase the signal intensity and contrast in MRI.
GBCAs have been used worldwide for MRI scans. GBCAs are generally considered safe. In some cases, there have been reports of mild to moderate side effects. There have also been reports indicating that small traces of Gd might stay in the body for an extended period after scans. However, there is no clear evidence that this causes any serious or long term problems in patients with normal kidney function.
There are different brands of GBCAs such as Gadovist and Magnevist. Knowledge about the safety of Gadovist and Magnevist in the Indian population is limited.
This study aims to enhance the currently available information on GBCAs and gather more information on the safety of Gadovist and Magnevist in the Indian population during GBCA enhanced MRI procedures in routine practice.
To do this, researchers will collect the following information:
- any possible medical problems occurring immediately after receiving GBCAs (Gadovist and Magnevist), and after 4 and 12 weeks of receiving GBCAs
- frequency of reporting medical problems after the use of GBCAs (Gadovist and Magnevist)
Patients will be asked to take part in the study only after confirming that they need a GBCA enhanced MRI, and the GBCA brand is already identified.
Data will be collected from February 2024 to September 2024. Healthcare professionals will collect safety data from selected sites which frequently conduct GBCA enhanced MRIs for patients who have not received GBCAs before.
Every patient scheduled for an MRI with contrast agents will be followed up at approximately 4 and 12 weeks after the GBCA enhanced MRI.
In this study, only safety data from routine practice are collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GBCA-naïve male/female patients of at least 18 years of age.
- •willing to participate in the active surveillance and agree to be contacted by phone after 6 (±2) weeks after the MR scan for brief interviews.
排除标准
- 未提供
研究组 & 干预措施
Patients require GBCA-enhanced MRI
Patients who are scheduled to undergo magnetic resonance imaging (MRI) with gadolinium-based contrast agent (GBCA) enhancement as per routine clinical practice.
干预措施: GBCAs (Drug)
结局指标
主要结局
Number of adverse events reported after use of branded gadolinium-based contrast agent (GBCA).
时间窗: Immediately post dose and at 6 (±2) weeks post dose
Number for participants with adverse events after use of a branded GBCA
时间窗: From injection of GBCAs up to 6 (±2) weeks
次要结局
未报告次要终点