EUCTR2012-001439-30-ES进行中（未招募）1 期
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. - Long-Term Retention of Gadolinium in Bone
Ecron Acunova GmbH0 个研究点目标入组 350 人开始时间: 2013年4月9日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Patient must be at least 18 years of age (or older if required by local regulations)
- •2. Patient scheduled for hip or knee replacement
- •3. Patient is scheduled to have sufficient bone removed during the hip or knee surgical replacement procedure and sufficient non-scarred skin tissue from the edge of the surgical incision to permit sample collection, in the investigator?s medical opinion
- •4. Patient agreed to have bone and skin samples collected at the time of the surgical procedure(s)
- •5. Patient?s surgical procedure and subsequent remission will not be altered by study-specific skin biopsies, in the investigator?s medical opinion
- •6. Patient is fully informed about the study and has signed the informed consent form
- •Concerning patients having received GdCA:
- •7. Patient belongs to one of the following subgroups with respect to the number of GdCA doses received and the status of their renal function:
- •a) patient (total to enrol = 5) has stable severe renal impairment (eGFR < 30 ml/min/ 1.73 m²) and has received one GdCA 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)
- •b) patient (total to enrol = 5) has stable severe renal impairment (eGFR < 30 ml/min/ 1.73 m²) and has received more than one injection of the same GdCA
- •c) patient (total to enrol = 5) has stable moderate renal impairment (eGFR within the range 30 to 60 ml/min/1.73 m²) and has received one GdCA 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)
- •d) patient (total to enrol = 5) has stable moderate renal impairment (eGFR within the range 30 to 60 ml/min/1.73 m²) and has received more than one injection of the same GdCA
- •e) patient (total to enrol = 5) has stable renal function (eGFR > 60 ml/min /1.73 m²) and has received one GdCA 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)
- •f) patient (total to enrol = 5) has stable renal function (eGFR > 60 ml/min /1.73 m²) and has received more than one injection the same GdCA.
- •8. A minimum of 3 months have elapsed between GdCA dose and scheduled hip or knee replacement.
- •9. Patient GdCA history, including dose(s), date(s), and product(s) administered is complete and accurate.
- •Concerning GdCA naïve patients (control group):
- •10. Patient has never received GdCA before hip / knee replacement.
- •11. Patient belongs to one of the following renal function categories:
- •g) patient (total to enrol = 5) has stable severe renal impairment (eGFR < 30 ml/ min/1.73 m²);
- •h) patient (total to enrol = 5) has stable moderate renal impairment (eGFR within the range 30 to 60 ml/min/1.73 m2);
- •i) patient (total to enrol = 5) has stable renal function (eGFR > 60 ml/min /1.73 m²).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for
排除标准
- •1. Patient has received different GdCAs.
- •2. Patient has received intra-articular GdCA or per any other non-i.v. route.
- •3. Patient has received or is scheduled to receive GdCA within 3 months prior to the date of hip or knee replacement surgery and study sample collection procedures.
- •4. Patient has received any investigational product or has participated in any other clinical trial within 30 days prior to enrolling in this study.
- •5. Patient suspected of, or diagnosed with, tumour in knee / hip bone, metastatic bone and bone marrow disease in knee / hip.
- •Note: Patients shall not be excluded for other bone diseases with the exception of those with bone cancer as specified in exclusion criterion 5.
- •6. Patient has diagnosed or suspected NSF at time of enrolment.
- •Note: Patients shall not be excluded for diagnosis of NSF subsequent to enrolment.
- •7. Patient presents with scarring in the region(s) of the scheduled surgical procedure(s) or of the skin sampling location, to the extent that collection of an unscarred skin sample is not feasible.
- •8. Patient has a close affiliation with the investigational site; e.g., a relative of the investigator, dependent person (e.g., employee or student of the investigational site).
研究者
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暂停
不适用
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