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Trial record 1 of 1 for:    NCT01853163
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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
Sponsor:
Information provided by (Responsible Party):
Navitas Life Sciences GmbH

Brief Summary:

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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).

  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Patient scheduled for an orthopaedic surgical procedure
  • A minimum of 1 month has elapsed between Gadolinium contrast agent (GdCA) dose and scheduled orthopaedic surgical procedure
  • Patient belongs to one of the following subgroups with respect to the number of GdCA 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 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) 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 GdCA or
    3. patient 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) 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 GdCA

Main Exclusion Criteria:

  • Patient has received different GdCAs.
  • Patient has received intra-articular GdCA 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.

Information from the National Library of Medicine

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


Locations
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United States, California
Cedar-Sinai Medical Center
Los Angeles, California, United States, 90048
Germany
University Hospital Halle (Saale)
Halle (Saale), Germany, 06097
University Hospital Magdeburg
Magdeburg, Germany, 39120
University Hospital Würzburg
Würzburg, Germany, 97074
Japan
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
Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, Spain, 28922
Hospital Vall d'Hebron
Barcelona, Spain, 08035
H.G.U. Gregorio Marañón
Madrid, Spain, 28007
Turkey
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
Istanbul, Turkey
Dokuz Eylul University Tıp Faculty
Izmir, Turkey, 35340
Sponsors and Collaborators
Navitas Life Sciences GmbH
Investigators
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Principal Investigator: Christoph Lohmann, Professor MD University Hospital Magdeburg, Germany
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Responsible Party: Navitas Life Sciences GmbH
ClinicalTrials.gov Identifier: NCT01853163    
Other Study ID Numbers: ALS-Gd64/001
First Posted: May 14, 2013    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: February 2020
Keywords provided by Navitas Life Sciences GmbH:
Gadolinium
Contrast Agent
Long-term retention