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.
- Conditions
- - MRI with Gadolinium Contrast Agent received (independent of indication) - Hip or knee surgery planned
- Registration Number
- JPRN-UMIN000011916
- Lead Sponsor
- Ecron Acunova GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 350
Not provided
No patient may enter the study if any of the following exclusion criteria are fulfilled: 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 3 months prior to the date of hip or knee replacement surgery 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 in knee / hip bone, metastatic bone and bone marrow disease in knee / hip. Note: Patients shall not be excluded for other bone diseases with the exception of those with bone cancer as specified in exclusion criterion 5. 6. Patient has diagnosed or suspected NSF at time of enrolment. Note: Patients shall not be excluded for diagnosis of NSF subsequent to 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
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary evaluation variables: - Concentration of total Gd in trabecular bone (determined by ICP-MS). - Concentration of total Gd in cortical bone (determined by ICP-MS).
- Secondary Outcome Measures
Name Time Method Secondary evaluation variables: - Concentration of total Gd in skin tissue samples (determined by ICP-MS), collected at the time of hip or knee replacement surgery, from a biopsy from the edge of the sur¬gical wound. - Concentrations of calcium, phosphorus, sodium, iron, zinc and potassium in bone (both trabecular and cortical) and skin tissue samples (determined by ICP-MS or al-ternatively ICP-AES if the feasibility evaluation of ICP-MS does not show reliable re¬sults). - Histopathological evaluation of skin samples with regard to the possibility of findings associated with NSF (determined by an experienced dermatopathologist). - Description of potential co-factors for NSF, susceptibility factors and drug treatments with potential impact on bone metabolism.