Long-Term Retention of Gadolinium in Bone

Navitas Life Sciences GmbH92 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

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

Interventions

Gadolinium analysis in bone and tissue samplesPROCEDURE

Gadolinium analysis in bone and tissue samples from patients undergoing an orthopaedic surgical procedure who had received GBCAs in the past.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Main 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 Main 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

Outcomes

Primary Outcomes

Concentration of Total Gadolinium in Trabecular Bone

Concentration of total Gd in trabecular bone determined by ICP-MS

Time frame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)

Concentration of Total Gadolinium in Cortical Bone

Concentration of total Gd in cortical bone determined by ICP-MS

Time frame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)

Secondary Outcomes

Concentration of Total Gd in Skin Tissue Samples

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 was taken.

Time frame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)

Concentration of Calcium in Skin Tissue Samples

Concentration of calcium in skin tissue samples determined by ICP-MS

Time frame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)

Concentration of Calcium in Cortical Bone Tissue Samples

Concentration of calcium in cortical bone tissue samples determined by ICP-MS

Time frame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)

Concentrations of Phosphorus in Cortical Bone Tissue Samples

Concentrations of phosphorus in cortical bone tissue samples determined by ICP-MS

Time frame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)

Data from ClinicalTrials.gov

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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

...and 6 more locations

Concentrations of Sodium in Cortical Bone Tissue Samples

Concentrations of sodium in cortical bone tissue samples determined by ICP-MS

Time frame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)

Concentrations of Zinc in Bone Tissue Samples (Cortical)

Concentrations of zinc in cortical bone tissue samples determined by ICP-MS

Time frame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)

Concentration of Potassium in Cortical Bone Tissue Samples

Concentration of potassium in bone (cortical) tissue samples determined by ICP-MS

Time frame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)

Concentrations of Iron in Cortical Bone Tissue Samples

Concentrations of iron in bone (cortical) tissue samples determined by ICP-MS

Time frame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)

Concentration of Calcium in Trabecular Bone Tissue Samples

Concentrations of calcium in trabecular bone tissue samples determined by ICP-MS

Time frame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)

Concentration of Phosphorus in Trabecular Bone Tissue Samples

Concentrations of phosphorus in bone (trabecular) tissue samples determined by ICP-MS

Time frame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)

Concentrations of Sodium in Trabecular Bone Tissue Samples

Concentrations of sodium in trabecular bone tissue samples determined by ICP-MS

Time frame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)

Concentrations of Zinc in Trabecular Bone Tissue Samples

Concentrations of zinc in trabecular bone tissue samples determined by ICP-MS

Time frame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)

Concentrations of Potassium in Trabecular Bone Tissue Samples

Concentrations of potassium in trabecular bone tissue samples determined by ICP-MS

Time frame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)

Concentrations of Iron in Trabecular Bone Tissue Samples

Concentrations of iron in trabecular bone tissue samples determined by ICP-MS

Time frame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)

Concentrations of Phosphorus in Skin Tissue Samples

Concentrations of phosphorus in skin tissue samples determined by ICP-MS

Time frame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)

Concentrations of Sodium in Skin Tissue Samples

Concentrations of sodium in skin tissue samples determined by ICP-MS

Time frame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)

Concentrations of Zinc in Skin Tissue Samples

Concentrations of zinc in skin tissue samples determined by ICP-MS

Time frame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)

Concentration of Potassium in Skin Tissue Samples

Concentration of potassium in skin tissue samples determined by ICP-MS

Time frame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)

Concentration of Iron in Skin Tissue Samples

Concentration of iron in skin tissue samples determined by ICP-MS

Time frame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)