Exploratory Evaluation of the Potential for Long-term Retention of Gadolinium in the Bones of Patients Who Have Received Gadolinium Based Contrast Agents According to Their Medical History
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 31
- 主要终点
- Concentration of Total Gadolinium in Trabecular Bone
研究概览
简要总结
The main objective was to prospectively explore the potential for long-term retention of Gadolinium (Gd) in bones in patients who have received a single dose of Gadolinium-based contrast agents (GBCA) or multiple doses of the same GBCA, with moderate or severe renal impairment or stable normal renal function (eGFR > 60 ml/min/1.73 m2) at the time of GBCA injection.
详细描述
In order to collect additional clinical data this study was requested by the European Medicines Agency to further investigate whether Gd in human bone and skin are detectable for a long time after administration of GBCAs in patients with impaired renal function who had previously received any of the six different contrast agents (Gadobutrol, Gadodiamide, Gadopentetic acid, Gadoteric acid, Gadoversetamide, and Gadoxetic acid) within a magnetic resonance contrast imaging procedure and who are scheduled for an orthopaedic surgical procedure.
For this study the patients have not been administered any GBCA.
Participating sites are located in Germany, Italy, Poland, Spain, Turkey, USA, Japan, India and Republic of Korea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Main Inclusion Criteria:
- •Patient scheduled for an orthopaedic surgical procedure
- •A minimum of 1 month has elapsed between GBCA dose and scheduled orthopaedic surgical procedure
- •Patient belongs to one of the following subgroups with respect to the number of GBCA doses received and the status of their renal function:
- •patient has stable impaired renal function (at least moderate impairment, eGFR ≤ 60 ml/min/1.73 m2) and has received one GBCA injection at the standard dose (0.025 mmol per kg body weight for Gadoxetic acid and 0.1 mmol per kg body weight for all other agents) or
- •patient has stable impaired renal function (at least moderate impairment, eGFR ≤ 60 ml/min/1.73 m2) and has received more than one injection of the same GBCA or
- •patient has stable normal renal function (eGFR > 60 ml/min /1.73 m2) and has received one GBCA injection at the standard dose (0.025 mmol per kg body weight for Gadoxetic acid and 0.1 mmol per kg body weight for all other agents) or
- •patient has stable normal renal function (eGFR > 60 ml/min/1.73 m2) who have received more than one injection of the same GBCA
排除标准
- •Patient has received different GBCAs.
- •Patient has received intra-articular GBCA or per any other non-i.v. route
- •Patient has received any investigational product or has participated in any other clinical trial within 30 days prior to enrolling in this study.
结局指标
主要结局
Concentration of Total Gadolinium in Trabecular Bone
时间窗: Day 0 (visit 2, surgery); optional visit 6 (second surgery)
Concentration of total Gd in trabecular bone determined by ICP-MS
Concentration of Total Gadolinium in Cortical Bone
时间窗: Day 0 (visit 2, surgery); optional visit 6 (second surgery)
Concentration of total Gd in cortical bone determined by ICP-MS
次要结局
- Concentrations of Sodium in Cortical Bone Tissue Samples(Day 0 (visit 2, surgery); optional visit 6 (second surgery))
- Concentration of Potassium in Cortical Bone Tissue Samples(Day 0 (visit 2, surgery); optional visit 6 (second surgery))
- Concentration of Calcium in Trabecular Bone Tissue Samples(Day 0 (visit 2, surgery); optional visit 6 (second surgery))
- Concentrations of Sodium in Skin Tissue Samples(Day 0 (visit 2, surgery); optional visit 6 (second surgery))
- Concentrations of Zinc in Trabecular Bone Tissue Samples(Day 0 (visit 2, surgery); optional visit 6 (second surgery))
- Concentrations of Iron in Trabecular Bone Tissue Samples(Day 0 (visit 2, surgery); optional visit 6 (second surgery))
- Concentrations of Phosphorus in Skin Tissue Samples(Day 0 (visit 2, surgery); optional visit 6 (second surgery))
- Concentrations of Potassium in Trabecular Bone Tissue Samples(Day 0 (visit 2, surgery); optional visit 6 (second surgery))
- Concentration of Potassium in Skin Tissue Samples(Day 0 (visit 2, surgery); optional visit 6 (second surgery))
- Concentration of Iron in Skin Tissue Samples(Day 0 (visit 2, surgery); optional visit 6 (second surgery))
- Concentrations of Zinc in Bone Tissue Samples (Cortical)(Day 0 (visit 2, surgery); optional visit 6 (second surgery))
- Concentrations of Iron in Cortical Bone Tissue Samples(Day 0 (visit 2, surgery); optional visit 6 (second surgery))
- Concentrations of Sodium in Trabecular Bone Tissue Samples(Day 0 (visit 2, surgery); optional visit 6 (second surgery))
- Concentration of Total Gd in Skin Tissue Samples(Day 0 (visit 2, surgery); optional visit 6 (second surgery))
- Concentration of Calcium in Skin Tissue Samples(Day 0 (visit 2, surgery); optional visit 6 (second surgery))
- Concentration of Calcium in Cortical Bone Tissue Samples(Day 0 (visit 2, surgery); optional visit 6 (second surgery))
- Concentrations of Phosphorus in Cortical Bone Tissue Samples(Day 0 (visit 2, surgery); optional visit 6 (second surgery))
- Concentrations of Zinc in Skin Tissue Samples(Day 0 (visit 2, surgery); optional visit 6 (second surgery))
- Concentration of Phosphorus in Trabecular Bone Tissue Samples(Day 0 (visit 2, surgery); optional visit 6 (second surgery))