Long-Term Retention of Gadolinium in Bone

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

NCT01853163•Navitas Life Sciences GmbH

View on ClinicalTrials.gov

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) 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.

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 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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:
•1. 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
•2. 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
•3. 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
•4. patient has stable normal renal function (eGFR \> 60 ml/min/1.73 m2) who have received more than one injection of the same GBCA

Exclusion Criteria

•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.

Locations (16)

Cedar-Sinai Medical Center

Los Angeles, California, United States

University Hospital Halle (Saale)

Halle, Germany

University Hospital Magdeburg

Magdeburg, Germany

University Hospital Würzburg

Würzburg, Germany

Fukuoka Orthopaedic Hospital

Fukuoka, Japan

Nissan Tamagawa Hospital

Tokyo, Japan

Asan Medical Center Orthopedic Surgery

Seoul, South Korea

SMG-SNU Boramae Medical Center

Seoul, South Korea

Hospital Universitario Fundación Alcorcón

Alcorcón, Spain

Hospital Vall d'Hebron

Barcelona, Spain

Key Dates

Start Date

May 6, 2013

Primary Completion Date

December 5, 2018

Completion Date

December 17, 2018

Last Updated

September 28, 2022

Enrollment

ACTUAL participants

Conditions

Focus: Long-term Retention of Gadolinium-based Contrast Agent

Interventions

Gadolinium analysis in bone and tissue samples

PROCEDURE