In Vitro Study of the Effect of Gadolinium Contrast on Fibrocytes
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- total number of circulating fibrocytes
研究概览
简要总结
Gadolinium contrast agents are frequently administered for MRI imaging. Very little is known of its toxicity outside of patients with reduced renal function.
详细描述
Gadolinium contrast is administered to patients during MRI imaging. Recently, the investigators have observed potential gadolinium toxicity in some patients. To investigate this, the investigators propose to collect clinical data and lab data obtained as a part of clinical care. The investigators also plan to obtain 25 cc of peripheral blood at 2-4 weeks, 4-6 weeks and again at 3 months to identify unique monocyte signatures, gene polymorphisms, and to quantitate circulating fibrocytes (in fresh blood and after culture). Plan to enroll 15 patients with kidney, pancreas or liver transplant and exposed to gadolinium contrast agents, 15 non-transplant patients exposed to gadolinium contrast and 30 age- and sex-matched healthy controls not exposed to gadolinium contrast.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Renal, pancreas or liver transplant OR those without organ transplant OR controls
- •Age 18-70
- •Both gender
- •Exposure to gadolinium contrast agents (no exposure in controls)
- •Have had a transplant, have had a contrast dye with an MRI
- •Have not had a transplant and have had a contrast dye with an MRI
- •Healthy person who has not had an MRI or gadolinium for any other reason.
排除标准
- •End stage kidney disease or Stage 5
- •Previous diagnosis of Nephrogenic Systemic Fibrosis
研究组 & 干预措施
Transplant patients, MRI with Gadolinium contrast dye
Patients with kidney, pancreas or liver transplant and exposed to gadolinium contrast agents.
干预措施: Gadolinium contrast dye (Drug)
Non-transplant patients, MRI with Gadolinium contrast dye
Non-transplant patients exposed to gadolinium contrast.
干预措施: Gadolinium contrast dye (Drug)
结局指标
主要结局
total number of circulating fibrocytes
时间窗: 2-4 weeks
2-4 weeks after gadolinium contrast exposure
次要结局
未报告次要终点