Long-Term Retention of Gadolinium in Bone

NCT ID: NCT01853163

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-06
• Study Completion Date: 2018-12-17

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

GBCA

Patients who have received GBCAs in the past

Group Type: OTHER

Gadolinium analysis in bone and tissue samples

Intervention Type: PROCEDURE

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

Interventions

Gadolinium analysis in bone and tissue samples

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

GE Healthcare

INDUSTRY

Sponsor Role: collaborator

Guerbet

INDUSTRY

Sponsor Role: collaborator

Navitas Life Sciences GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Lohmann, Professor MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Magdeburg, Germany

Locations

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

H.G.U. Gregorio Marañón

Madrid, , Spain

Koc University Hospital, Orthopaedics and Traumatology Department

Istanbul, , Turkey (Türkiye)

Acibadem Hospital, Department of Orthopaedics and Traumatology

Istanbul, , Turkey (Türkiye)

Fatih Sultan Mehmet Training and Research Hospital, Department of Orthopedics and Traumatology

Istanbul, , Turkey (Türkiye)

Istanbul Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi

Istanbul, , Turkey (Türkiye)

Dokuz Eylul University Tıp Faculty

Izmir, , Turkey (Türkiye)

Countries

United States; Germany; Japan; South Korea; Spain; Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ALS-Gd64/001

Identifier Type: -

Identifier Source: org_study_id