N/A
N=92
Long-Term Retention of Gadolinium in Bone
Focus: Long-term Retention of Gadolinium-based Contrast Agent
Bottom Line
View on ClinicalTrials.gov: NCT01853163 ↗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
| Outcome | Result | p-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.
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.