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10月1日最近更新: 2023年10月17日

适应症

试验速览

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•No patient may enter the study if any of the following exclusion criteria are fulfilled: 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).

发起方

Ecron Acunova GmbH