Evaluation of Gd Retention in Human Bone and Skin After MultiHance or ProHance Administration Compared With Control
Completed
Conditions studied: Gadolinium Retention
In brief
Subjects must be scheduled to undergo an orthopedic surgical procedure. Subjects in the non-control group must have previously received an MRI with MultiHance or ProHance with at least 1 month between the last administration and the scheduled surgery. Subjects who have never received MultiHance or ProHance or any other gadolinium agent will also be enrolled. Subjects must have a test of their kidney function (SCr) at the time of the last MRI examination or at the time of enrollment if they never received gadolinium. A sample of bone and skin will be collected from the scheduled surgery and tested for the amount of gadolinium. An additional sample of skin will be collected for testing the presence of nephrogenic systemic fibrosis (NSF).
Key facts
- Study ID
- NCT03108378
- Run by
- Bracco Diagnostics, Inc
- People needed
- 28
- Starts
- 2014-10-01
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2020-08-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- SUBJECTS WHO RECEIVED MULTIHANCE or PROHANCE:
- Is scheduled to receive hip, shoulder or knee replacement surgery, limb amputations or other orthopedic surgical procedures
- Has undergone at least one MULTIHANCE or PROHANCE administration at least 1 month before his/her scheduled surgery
- Has a documented SCr for calculation of eGFR and/or documented eGFR at time of last MRI with MULTIHANCE or PROHANCE
- Provides written Informed Consent and is willing to comply with protocol requirements
- Is willing to undergo deep skin tissue sampling during scheduled hip, shoulder or knee replacement surgery, limb amputations or other orthopedic surgical procedures
- Is ≥18 years of age
- SUBJECTS WITH NO EXPOSURE TO GBCA:
- Is scheduled to receive hip, shoulder or knee replacement surgery, limb amputations or other orthopedic surgical procedures
- Has no history of GBCA administration
- Provides written Informed Consent and is willing to comply with protocol requirements
- Is willing to undergo deep skin tissue sampling during scheduled hip, shoulder or knee replacement surgery, limb amputations or other orthopedic surgical procedures
- Has prior SCr and/or eGFR at time of enrollment
- Is ≥18 years of age
You may not qualify if…
- SUBJECTS WHO RECEIVED MULTI HANCE or PROHANCE:
- Has undergone any GBCA including MULTIHANCE or PROHANCE administration less than 1 month before his/her scheduled surgery
- Has ever been suspected of, or diagnosed with, NSF
- Has been suspected or diagnosed, prior to inclusion in this study, with bone cancer or any other osteoblastic or osteoclastic disease, such as septic, infectious or ischemic disease affecting physiological bone structure that has caused the bone to be diseased, prior to inclusion in this study
- Is unable or unwilling to be examined by dermatologists or to undergo laboratory/other diagnostic evaluations should development of NSF be suspected.
- Has received any GBCA other than the one under evaluation at any time prior to inclusion in this study (e.g., a MULTIHANCE subject should not receive any other GBCA including PROHANCE)
- SUBJECTS WITH NO EXPOSURE TO GBCA:
- Has received any GBCA at any time prior to inclusion in this study
- Has ever been suspected of, or diagnosed with, NSF prior to the enrollment
- Has been suspected or diagnosed with bone cancer or any other osteoblastic or osteoclastic disease, such as septic, infectious or ischemic disease affecting physiological bone structure that has caused the bone to be diseased prior to inclusion in this study
- Is unable or unwilling to be examined by dermatologists or to undergo laboratory/other diagnostic evaluations should development of NSF be suspected.
Where it is running
- VA San Diego Healthcare System — San Diego, California, United States
Full record on ClinicalTrials.gov
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