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N/A N=92 Screening

Long-Term Retention of Gadolinium in Bone

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

Enrolled (actual)
92
Serious AEs
5.4%
Results posted
Sep 2022
Primary outcome: Primary: Concentration of Total Gadolinium in Trabecular Bone — 0.335; 0.783; 0; 0 micrograms/gram

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Gadolinium analysis in bone and tissue samples (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Navitas Life Sciences GmbH
Primary completion
Dec 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Concentration of Total Gadolinium in Trabecular Bone
0.335; 0.783; 0; 0
PRIMARY
Concentration of Total Gadolinium in Cortical Bone
0.298; 0.680; 0; 0
SECONDARY
Concentration of Total Gd in Skin Tissue Samples
0; 0; 0; 0
SECONDARY
Concentration of Calcium in Skin Tissue Samples
653.268; 651.478; 474.377; 790.700
SECONDARY
Concentration of Calcium in Cortical Bone Tissue Samples
96908.336; 92491.896; 142662.680; 118447.534
SECONDARY
Concentrations of Phosphorus in Cortical Bone Tissue Samples
52361.735; 50247.073; 73151.974; 62689.679
SECONDARY
Concentrations of Sodium in Cortical Bone Tissue Samples
5642.001; 5768.821; 5437.226; 5511.498
SECONDARY
Concentrations of Zinc in Bone Tissue Samples (Cortical)
78.516; 79.900; 92.622; 89.539
SECONDARY
Concentration of Potassium in Cortical Bone Tissue Samples
488.128; 543.211; 541.822; 426.705
SECONDARY
Concentrations of Iron in Cortical Bone Tissue Samples
38.807; 41.116; 57.069; 32.293
SECONDARY
Concentration of Calcium in Trabecular Bone Tissue Samples
124671.921; 116601.987; 145859.369; 143735.414
SECONDARY
Concentration of Phosphorus in Trabecular Bone Tissue Samples
65887.298; 62333.483; 74988.227; 74435.230
SECONDARY
Concentrations of Sodium in Trabecular Bone Tissue Samples
4743.199; 4514.245; 4681.874; 4580.294
SECONDARY
Concentrations of Zinc in Trabecular Bone Tissue Samples
83.812; 85.312; 89.849; 93.524
SECONDARY
Concentrations of Potassium in Trabecular Bone Tissue Samples
394.953; 461.425; 679.490; 340.698
SECONDARY
Concentrations of Iron in Trabecular Bone Tissue Samples
40.142; 42.889; 62.371; 23.709
SECONDARY
Concentrations of Phosphorus in Skin Tissue Samples
1023.978; 1038.525; 1075.359; 1129.268
SECONDARY
Concentrations of Sodium in Skin Tissue Samples
3711.129; 4146.187; 4660.517; 4871.197
SECONDARY
Concentrations of Zinc in Skin Tissue Samples
24.639; 28.767; 27.692; 23.537
SECONDARY
Concentration of Potassium in Skin Tissue Samples
1011.939; 1132.855; 1418.726; 1121.846
SECONDARY
Concentration of Iron in Skin Tissue Samples
69.452; 103.432; 145.362; 99.477

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.

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:
  • 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

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01853163). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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