Clinical trial NCT01853163: Long-Term Retention of Gadolinium in Bone
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focus: Long-term Retention of Gadolinium-based Contrast Agent
Keywords: Gadolinium
Contrast Agent
Long-term retention
Lead sponsor: Navitas Life Sciences GmbH
Sponsor class: INDUSTRY
Collaborators: name: Bayer
name: GE Healthcare
name: Guerbet
First posted: 2013-05-14
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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) 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 criteria: 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.

Primary outcomes:
measure: Concentration of Total Gadolinium in Trabecular Bone
timeFrame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)
measure: Concentration of Total Gadolinium in Cortical Bone
timeFrame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)
Secondary outcomes:
measure: Concentration of Total Gd in Skin Tissue Samples
timeFrame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)
measure: Concentration of Calcium in Skin Tissue Samples
timeFrame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)
measure: Concentration of Calcium in Cortical Bone Tissue Samples
timeFrame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)
measure: Concentrations of Phosphorus in Cortical Bone Tissue Samples
timeFrame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)
measure: Concentrations of Sodium in Cortical Bone Tissue Samples
timeFrame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)
measure: Concentrations of Zinc in Bone Tissue Samples (Cortical)
timeFrame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)
measure: Concentration of Potassium in Cortical Bone Tissue Samples
timeFrame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)
measure: Concentrations of Iron in Cortical Bone Tissue Samples
timeFrame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)
measure: Concentration of Calcium in Trabecular Bone Tissue Samples
timeFrame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)
measure: Concentration of Phosphorus in Trabecular Bone Tissue Samples
timeFrame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)
measure: Concentrations of Sodium in Trabecular Bone Tissue Samples
timeFrame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)
measure: Concentrations of Zinc in Trabecular Bone Tissue Samples
timeFrame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)
measure: Concentrations of Potassium in Trabecular Bone Tissue Samples
timeFrame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)
measure: Concentrations of Iron in Trabecular Bone Tissue Samples
timeFrame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)
measure: Concentrations of Phosphorus in Skin Tissue Samples
timeFrame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)
measure: Concentrations of Sodium in Skin Tissue Samples
timeFrame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)
measure: Concentrations of Zinc in Skin Tissue Samples
timeFrame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)
measure: Concentration of Potassium in Skin Tissue Samples
timeFrame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)
measure: Concentration of Iron in Skin Tissue Samples
timeFrame: Day 0 (visit 2, surgery); optional visit 6 (second surgery)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedar-Sinai Medical Center
state: California
city: Halle (Saale)
country: Germany
facility: University Hospital Halle (Saale)
city: Magdeburg
country: Germany
facility: University Hospital Magdeburg
city: Würzburg
country: Germany
facility: University Hospital Würzburg
city: Fukuoka
country: Japan
facility: Fukuoka Orthopaedic Hospital
city: Tokyo
country: Japan
facility: Nissan Tamagawa Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center Orthopedic Surgery
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcón
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Madrid
country: Spain
facility: H.G.U. Gregorio Marañón
city: Istanbul
country: Turkey
facility: Koc University Hospital, Orthopaedics and Traumatology Department
city: Istanbul
country: Turkey
facility: Acibadem Hospital, Department of Orthopaedics and Traumatology
city: Istanbul
country: Turkey
facility: Fatih Sultan Mehmet Training and Research Hospital, Department of Orthopedics and Traumatology
city: Istanbul
country: Turkey
facility: Istanbul Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi
city: Izmir
country: Turkey
facility: Dokuz Eylul University Tıp Faculty
Study officials:
affiliation: University Hospital Magdeburg, Germany
name: Christoph Lohmann, Professor MD
role: PRINCIPAL_INVESTIGATOR
References: