Kinetics of Urinary Excretion of Gadolinium Contrast Agents Used in MRI Examinations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Urinary excretion of gadolinium-based contrast agents (Gd-CAs)
研究概览
简要总结
This is a single-center cohort study aimed to describe the urinary excretion kinetics of gadolinium contrast agents (Gd-CAs). Patients with a prescription for injected MRI are invited to participate in the study. If they agree, blood and urine samples are collected before Gd-CAs injection, and urine samples are collected between 0- and two-and-a-half-hours post-injection of Gd-CAs.
详细描述
The contrast agents used in MRI to characterize certain lesions contain a chemical element from the rare earth family: Gadolinium (Gd). Gd, in its isolated form, is toxic in humans, but it can still be used in the form of complex molecules such as gadolinium contrast agents (Gd-CAs), which retain its contrast power while greatly minimizing its toxicity.
The MRI is performed rapidly after the injection of Gd-CAs, and these compounds are eliminated by the urinary route in the first urine following the examination. After elimination, and in view of their very high stability, these compounds follow the path of wastewater via sewage treatment plants. However, the processes currently used in these plants do not retain them, and they remain present in the purified water discharged into rivers.
Work carried out at the Laboratoire Interdisciplinaire des Environnements Continentaux (LIEC) at the University of Lorraine has demonstrated the bioaccumulation of these compounds in freshwater organisms. Gd-CAs then follow the classic pathway of continental waters. It should be noted that the quantity of Gd released as a result of MRI activities has been estimated on average at 1 injection per 1 g of Gd used.
In order to prevent future environmental disorders, recovery of all or part of the Gd-CAs immediately after MRI by urine collection is undoubtedly the most effective approach.
The aim of this project is to assess the feasibility of such an approach, and to propose a protocol applicable to MRI involving the injection of gadolinium contrast agents for urine collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •over 18 years of age
- •with a prescription for MRI with gadolinium-based contrast agents (Gd-CAs) injection validated by a radiologist
- •affiliated with a health insurance plan
- •have signed an informed consent form
排除标准
- •Patients:
- •with known allergy to gadolinium-based contrast agents (Gd-CAs)
- •with known severe renal impairment (GFR < 30 mL/min)
- •on dialysis
- •with urinary incontinence
- •with an ongoing urinary tract infection
- •under hydric or hydrosodic restriction
- •unable to urinate independently
- •Protected persons (under guardianship, curatorship or safeguard of justice)
- •Pregnant or breast-feeding women
研究组 & 干预措施
excretion kinetics of gadolinium contrast agents in patients
urine samples are collected before Gd-CAs injection, and between 0- and two-and-a-half-hour post-injection of Gd-CAs.
干预措施: biological samples collection (Other)
结局指标
主要结局
Urinary excretion of gadolinium-based contrast agents (Gd-CAs)
时间窗: at 2 hours and a half after Gd-CAs injection
Describe the kinetics of urinary excretion of GdCAs during the 2H30 following gadoline contrast injection in patients undergoing injected MRI at the Mercy Hospital Medical Imaging Department. The cumulative quantity of gadolinium-based contrast agents (Gd-CAs) (mg) mesured in urine during spontaneous micturition between 0 and 2H30 after injection of gadoline contrast medium and during micturition on demand at 2.30 h. The amount of Gd present in the urine (directly associated with the presence of Gd-CAs) is determined by inductively coupled plasma mass spectrometry (ICPMS). Urine concentrations are expressed in µg/L. Taking into account the volume of urine collected, the quantity of Gd is calculated and expressed in mg. This quantity is then expressed as a percentage of the quantity of injected-Gd-CAs.
次要结局
- Volume of beverages(at 2 hours and a half after Gd-CAs injection)
- Renal function(Day 0 (MRI))
- Time to first spontaneous micturition(up to 2 hours and a half after Gd-CAs injection)
- Study refusal rate(Day 0 (MRI))
- Rate of premature study exit(at 2 hours and a half after Gd-CAs injection)