Prolonged Gadolinium Retention After MRI Imaging in Patients With Normal Renal Function
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- gadolinium levels in urine before and after an edetate calcium disodium challenge
研究概览
简要总结
The researchers propose to investigate the prevalence of gadolinium in the urine of patients with a prior gadolinium-enhanced MRI before and after a edetate calcium disodium challenge. Moreover, will investigate if there is any correlation of gadolinium urine levels with levels of endogenous (e.g zinc) and xenobiotic metals.
详细描述
The investigators propose to enroll 20 volunteers in this pilot study, including males older than 20 years and postmenopausal women in two groups: Group 1: Individuals who had a gadolinium-enhanced MRI study within 1-4 weeks before participation and Group 2: Individuals who had gadolinium-enhanced MRI study within 3-6 months before enrollment. The results will inform future analyses of gadolinium retention, excretion, and potential symptoms associated with same.
Thus, the specific aims of this cross sectional study are to:
- Evaluate levels of gadolinium in the urine of adults with normal kidney function and a prior MRI performed within 6 months at baseline, and after a single dose of edetate calcium disodium .
- Evaluate levels of endogenous and xenobiotic metal levels and their relationship with gadolinium levels.
- Evaluate for symptoms of gadolinium toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who had a contrast enhanced MRI for any indication within 1-4 weeks or 3-6 months, and normal renal function assessed by normal glomerular filtration rate (GFR) >60 mL/min/1.73 m2 at the time of the gadolinium-enhanced MRI study.
排除标准
- •Allergy to edetate calcium disodium
- •Prior chelation therapy with edetate disodium since the administration of gadolinium
- •Blood pressure >160/100
- •No venous access
- •Platelet count <100,000/mm3
- •Liver disease or alanine transaminase (ALT) or aspartate transaminase (AST) >2.0 times the upper limit of normal
- •Diseases of copper, iron, or calcium metabolism
- •Women of child-bearing potential
- •History of lead intoxication; lead encephalopathy; cerebral edema.
研究组 & 干预措施
edetate calcium disodium
Subjects who had a gadolinium-enhanced MRI within 1-4 weeks or within 3-6 months before enrollment will receive a single dose of edetate calcium disodium to evaluate levels of gadolinium in their urine, pre and post infusion.
干预措施: edetate calcium disodium (Drug)
结局指标
主要结局
gadolinium levels in urine before and after an edetate calcium disodium challenge
时间窗: within 6 months of a gadolinium-enhanced MRI
次要结局
未报告次要终点
研究者
Gervasio Lamas, MD
Chair, Department of Medicine
Mt. Sinai Medical Center, Miami