CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 92 enrolled
Drug / intervention
Gadolinium analysis in bone and tissue samplesprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01853163
NCT01853163N/ACompleted

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

Navitas Life Sciences GmbH·interventional·Posted May 14, 2013·Updated Sep 28, 2022

In Brief

A clinical study evaluating Gadolinium analysis in bone and tissue samples for Focus: Long-term Retention of Gadolinium-based Contrast Agent. Completed, enrolled 92 participants across 16 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Japan, South Korea, Spain, Turkey (Türkiye), United States
CollaboratorsBayer, GE Healthcare, Guerbet

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 14, 2013
Enrollment StartMay 6, 2013
Primary CompletionDec 5, 2018
Study CompletionDec 17, 2018
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 13.1 years ago

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.