Long-Term Retention of Gadolinium in Bone

NCT01853163 | Completed Results

• 1 other identifier: ALS-Gd64/001
• Study Type: interventional
• Target: 92
• Locations: 6 countries
• Sites: 16

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.

Conditions

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

Keywords

Gadolinium; Contrast Agent; Long-term retention

Outcome Measures

Primary Outcomes (2)

• Concentration of Total Gadolinium in Trabecular Bone

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

  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

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

Secondary Outcomes (19)

• Concentration of Total Gd in Skin Tissue Samples

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

• Concentration of Calcium in Skin Tissue Samples

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

• Concentration of Calcium in Cortical Bone Tissue Samples

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

• Concentrations of Phosphorus in Cortical Bone Tissue Samples

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

• Concentrations of Sodium in Cortical Bone Tissue Samples

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

Study Arms (1)

GBCA

OTHER

Patients who have received GBCAs in the past

Procedure: Gadolinium analysis in bone and tissue samples

Interventions

Gadolinium analysis in bone and tissue samples PROCEDURE

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

GBCA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• 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
• 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
• patient has stable normal renal function (eGFR \> 60 ml/min/1.73 m2) who have received more than one injection of the same GBCA

You may not qualify if:

• 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.

Sponsors & Collaborators

• Navitas Life Sciences GmbH: lead
• Bayer: collaborator
• GE Healthcare: collaborator
• Guerbet: collaborator

Study Sites (16)

Cedar-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University Hospital Halle (Saale)

Halle, 06097, Germany

Location

University Hospital Magdeburg

Magdeburg, 39120, Germany

Location

University Hospital Würzburg

Würzburg, 97074, Germany

Location

Fukuoka Orthopaedic Hospital

Fukuoka, 815-0063, Japan

Location

Nissan Tamagawa Hospital

Tokyo, 158-0095, Japan

Location

Asan Medical Center Orthopedic Surgery

Seoul, 05505, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, 156-707, South Korea

Location

Hospital Universitario Fundación Alcorcón

Alcorcón, 28922, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

H.G.U. Gregorio Marañón

Madrid, 28007, Spain

Location

Koc University Hospital, Orthopaedics and Traumatology Department

Istanbul, 34010, Turkey (Türkiye)

Location

Acibadem Hospital, Department of Orthopaedics and Traumatology

Istanbul, 34303, Turkey (Türkiye)

Location

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

Istanbul, 34752, Turkey (Türkiye)

Location

Istanbul Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi

Istanbul, Turkey (Türkiye)

Location

Dokuz Eylul University Tıp Faculty

Izmir, 35340, Turkey (Türkiye)

Location

Limitations and Caveats

Due to EMA recommendation in July 2017 to restrict the use of linear gadolinium based contrast agents in body scans, the enrollment of impaired renal patients with a history of linear GdCA was restricted.

Results Point of Contact

• Title: Managing Director
• Organization: Navitas Life Sciences GmbH

marty.boom@navitaslifesciences.com

+49 (0) 69-66 80 30-0

Study Officials

• Christoph Lohmann, Professor MD

  University Hospital Magdeburg, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: May 14, 2013
• Study Start: May 6, 2013
• Primary Completion: December 5, 2018
• Study Completion: December 17, 2018
• Last Updated: September 28, 2022
• Results First Posted: September 28, 2022

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); KR (2); ES (3); TU (5); JP (2); US (1)