EUCTR2012-001439-30-DE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
avitas Life Sciences GmbH0 个研究点目标入组 135 人开始时间: 2013年1月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 135
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
- 性别
- All
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 an orthopaedic surgical procedure provided that the required amount of trans-operatory collection of bone and skin as defined per-protocol in section 5.1.3 is feasible and all inclusion and no exclusion criteria are met.
- •3.Patient is scheduled to have sufficient bone removed during the orthopaedic surgical procedure and sufficient non-scarred skin tissue from the edge of the surgical incision or amputated part 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
- •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 impaired renal function (at least moderate impairment, 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)
- •b)Up to 5 patients with 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 GdCA.
- •Gadodiamide, Gadopentetic acid, Gadoversetamide, and Gadoxetic acid groups: no target number. Patients should be recruited to this subgroup throughout the study duration, but there is no requirement to reach a specific number of patients in this subgroup to achieve study completion.
- •Gadobutrol and Gadoteric acid groups: at least 3 patients. If the target of 3 patients is reached, but the study has not yet completed, then recruitment to this group should be continued during the remaining study time.
- •c)patient (total to enrol = 5) has stable normal 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)
- •d)patient (total to enrol = 3 to 5) with stable normal renal function (eGFR > 60 ml/min/1.73 m2) who have received more than one injection of the same GdCA. If the target of 3 patients is reached, but the study has not yet been completed, then recruitment to this subgroup should be continued during the remaining study time, stopping when 5 patients have been recruited to this subgroup, or when all other subgroups have reached their minimum target for recruitment, whichever comes first.
- •8.A minimum of 1 month have elapsed between GdCA dose and the scheduled orthopaedic surgical procedure.
- •9.Patient GdCA history, including dose(s), date(s), and product(s) administered is com-plete and accurate.
- •GdCA naïve patients (control group):
- •10.Patient has never received GdCA before the scheduled orthopaedic surgical procedure.
- •11.Patient belongs to one of the following renal function categories:
- •e)patient (total to enrol = 5) has stable severe renal impairment (eGFR < 30 ml/ min/1.73 m2);
- •f)patient (total to enrol = 5) has stable moderate renal impairment (eGFR within the range 30 to 60 ml/min/1.73 m2);
- •g)patient (total to enrol = 5) has stable
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 1 month prior to the date of the scheduled orthopaedic surgical and study sample collection procedures.
- •4.Patient has received any investigational product or has participated in any other clini-cal trial within 30 days prior to enrolling in this study.
- •5.Patient suspected of, or diagnosed with, tumour of the skeletal system (i.e. tumour, metastatic bone, and bone marrow disease in the region from where the skin and bone will be harvested).
- •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 investi-gator, dependent person (e.g., employee or student of the investigational site).
研究者
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