Long-Term Retention of Gadolinium in Bone
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01853163|
Recruitment Status : Completed
First Posted : May 14, 2013
Last Update Posted : March 2, 2020
The purpose of the study is to further investigate the safety of six different commercially used Gadolinium-containing contrast agents.
The study has been developed to evaluate Gadolinium retention in patients with renal function ranging from stable to severely impaired renal function who had previously (i.e. before start of this study) received any of the six different contrast agents within a magnetic resonance contrast imaging procedure and who will now undergo an orthopaedic procedure that allows collection of bone and skin samples for analysis.
|Condition or disease||Intervention/treatment||Phase|
|Focus: Long-term Retention of Gadolinium Contrast Agent||Procedure: Gadolinium analysis in bone and tissue samples||Not Applicable|
The purpose of the study is to further investigate the safety of six different commercially used Gadolinium-containing contrast agents. In order to get a better view of internal organs such as the brain, joints and other body regions contrast agents containing Gadolinium are often administered during magnetic resonance imaging.
Gadolinium-containing contrast agents were introduced in the 1980s, and presently many different products are in common use. Although these agents are well tolerated, in 2006 it was reported that some patients with severe renal failure undergoing magnetic resonance contrast imaging developed signs of a rare condition known as Nephrogenic Systemic Fibrosis (NSF). NSF is an extremely rare disease that has predominantly been reported in patients with severe kidney impairment, acute kidney insufficiency due to the hepatorenal syndrome (kidney failure in patients with advanced chronic liver disease) or in patients with acute kidney insufficiency, who have recently had or soon expect to have a liver transplantation.
In order to collect additional clinical data on a global scale and across different agents in common use, this study was requested by the European Medicines Agency to further investigate whether Gadolinium in human bone and skin are retained for a long time after administration of Gadolinium-containing contrast agents. This study has been developed to evaluate Gadolinium retention in patients with renal function ranging from stable to severely impaired renal function who had previously received any of the six different contrast agents within a magnetic resonance contrast imaging procedure and who are scheduled for an orthopaedic procedure.
For this study the patients will not be administered any research medication.
Participating sites are located in Germany, Italy, Poland, Spain, Turkey, USA, Japan and Republic of Korea.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||February 22, 2019|
|Actual Study Completion Date :||July 12, 2019|
Gadolinium contrast agent
Patients who have received Gadolinium contrast agents in the past
Procedure: Gadolinium analysis in bone and tissue samples
Gadolinium analysis in bone and tissue samples from patients undergoing an orthopaedic surgical procedure who had received Gadolinium-containing contrast agents in the past.
- Concentration of total Gadolinium in (trabecular/cortical) bone [ Time Frame: Day 0 (visit 2); optional visit 6 ]Analysation of a single bone sample; in case of a second surgery a further sample will be taken
- Concentration of total Gd in skin tissue samples [ Time Frame: Day 0 (visit 2); optional visit 6 ]Concentration of total Gd in skin tissue samples (determined by ICP-MS (inductively coupled plasma mass spectrometry)), collected at the time of the scheduled orthopaedic surgical procedure, from a biopsy from the edge of the surgical wound or the amputated part. Analysation of a single skin tissue sample; in case of a second surgery a further sample will be taken.
- Concentrations of calcium, phosphorus, sodium, iron, zinc and potassium in bone and skin tissue samples [ Time Frame: Day 0 (visit 2); optional visit 6 ]Concentrations of calcium, phosphorus, sodium, iron, zinc and potassium in bone (both trabecular and cortical) and skin tissue samples (determined by ICP-MS or alternatively ICP-AES (inductively coupled plasma atomic emission spectroscopy) if the feasibility evaluation of ICP-MS does not show reliable results).
- Histopathological evaluation of skin samples with regard to the possibility of findings associated with NSF (determined by an experienced dermatopathologist) [ Time Frame: Day 0 (visit 2); optional visit 6 ]
- Description of potential co-factors for NSF, susceptibility factors and drug treatments with potential impact on bone metabolism [ Time Frame: Day 0 (visit 2); optional visit 6 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853163
|United States, California|
|Cedar-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|University Hospital Halle (Saale)|
|Halle (Saale), Germany, 06097|
|University Hospital Magdeburg|
|Magdeburg, Germany, 39120|
|University Hospital Würzburg|
|Würzburg, Germany, 97074|
|Fukuoka Orthopaedic Hospital|
|Fukuoka, Japan, 815-0063|
|Nissan Tamagawa Hospital|
|Tokyo, Japan, 158-0095|
|Korea, Republic of|
|Asan Medical Center Orthopedic Surgery|
|Seoul, Korea, Republic of, 05505|
|SMG-SNU Boramae Medical Center|
|Seoul, Korea, Republic of, 156-707|
|Hospital Universitario Fundación Alcorcón|
|Alcorcón, Spain, 28922|
|Hospital Vall d'Hebron|
|Barcelona, Spain, 08035|
|H.G.U. Gregorio Marañón|
|Madrid, Spain, 28007|
|Koc University Hospital, Orthopaedics and Traumatology Department|
|Istanbul, Turkey, 34010|
|Acibadem Hospital, Department of Orthopaedics and Traumatology|
|Istanbul, Turkey, 34303|
|Fatih Sultan Mehmet Training and Research Hospital, Department of Orthopedics and Traumatology|
|Istanbul, Turkey, 34752|
|Istanbul Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi|
|Dokuz Eylul University Tıp Faculty|
|Izmir, Turkey, 35340|
|Principal Investigator:||Christoph Lohmann, Professor MD||University Hospital Magdeburg, Germany|