A clinical trial to find out the capacity of Gadolinium to retain for longer time in bones of the patients who have received the Gadolinium based contrast Agents (GdCAs) for imaging purpose prior to participation in the trial.
- Conditions
- Health Condition 1: null- patients who have received Gadolinium based Contrast Agents (GdCAs) according to their medical history
- Registration Number
- CTRI/2018/02/012077
- Lead Sponsor
- Ecron Acunova GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Patient must be at least 18 years of age (or older if required by local regulations)
2.Patient scheduled for an orthopaedic surgical procedure provided that the required amount of trans-operatory collection of bone and skin as defined per-protocol in section 5.1.3 is feasible and all inclusion and no exclusion criteria are met.
3.Patient is scheduled to have sufficient bone removed during the orthopaedic surgical procedure and sufficient non-scarred skin tissue from the edge of the surgical incision or amputated part to permit sample collection, in the investigatorâ??s medical opinion
4.Patient agreed to have bone and skin samples collected at the time of the surgical procedure(s)
5.Patientâ??s surgical procedure and subsequent remission will not be altered by study specific skin biopsies, in the investigatorâ??s medical opinion
6.Patient is fully informed about the study and has signed the informed consent form
1.Patient has received different GdCAs.
2.Patient has received intra-articular GdCA or per any other non-i.v. route.
3.Patient has received or is scheduled to receive GdCA within 1 month prior to the date of the scheduled orthopaedic surgical and study sample collection procedures.
4.Patient has received any investigational product or has participated in any other clinical trial within 30 days prior to enrolling in this study.
5.Patient suspected of, or diagnosed with, tumour of the skeletal system i.e.tumour, metastatic bone, and bone marrow disease in the region from where the skin and bone will be harvested.
6.Patient has diagnosed or suspected NSF at time of enrolment.
7.Patient presents with scarring in the region(s) of the scheduled surgical procedure(s) or of the skin sampling location, to the extent that collection of an unscarred skin sample is not feasible.
8.Patient has a close affiliation with the investigational site; e.g., a relative of the investigator, dependent person (e.g., employee or student of the investigational site).
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Concentration of total Gd in trabecular bone (determined by ICP-MS). <br/ ><br> <br/ ><br>Concentration of total Gd in cortical bone (determined by ICP-MS).Timepoint: Visit 2 (Day 0, Surgery visit)
- Secondary Outcome Measures
Name Time Method Concentration of total Gd in skin tissue samples (determined by ICP-MS)Timepoint: Visit 2 (Day 0, Surgery visit);Concentrations of calcium, phosphorus, sodium, iron, zinc and potassium in bone <br/ ><br>(both trabecular and cortical) and skin tissue samplesTimepoint: Visit 2 (Day 0, Surgery visit);Description of potential co-factors for NSF, susceptibility factors and drug treatments with potential impact on bone metabolismTimepoint: Visit 2 (Day 0, Surgery visit);Histopathological evaluation of skin samples with regard to the possibility of findings associated with NSFTimepoint: Visit 2 (Day 0, Surgery visit)