Status:
COMPLETED
Long-Term Retention of Gadolinium in Bone
Lead Sponsor:
Navitas Life Sciences GmbH
Collaborating Sponsors:
Bayer
GE Healthcare
Conditions:
Focus: Long-term Retention of Gadolinium-based Contrast Agent
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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)...
Detailed Description
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 adm...
Eligibility Criteria
Inclusion
- Main
- 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
- Main
Exclusion
- 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.
Key Trial Info
Start Date :
May 6 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2018
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01853163
Start Date
May 6 2013
End Date
December 17 2018
Last Update
September 28 2022
Active Locations (16)
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1
Cedar-Sinai Medical Center
Los Angeles, California, United States, 90048
2
University Hospital Halle (Saale)
Halle, Germany, 06097
3
University Hospital Magdeburg
Magdeburg, Germany, 39120
4
University Hospital Würzburg
Würzburg, Germany, 97074