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Long-Term Retention of Gadolinium in Bone

NCT01853163 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2022-09-28

Study results available
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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

Interventions

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 GBCAs in the past.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • GE Healthcare

    collaborator INDUSTRY

  • Guerbet

    collaborator INDUSTRY

  • Navitas Life Sciences GmbH

    lead INDUSTRY

Principal Investigators

  • Christoph Lohmann, Professor MD · University Hospital Magdeburg, Germany

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-06
Primary Completion
2018-12-05
Completion
2018-12-17

Countries

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

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01853163 on ClinicalTrials.gov