Gadolinium Retention Clinical Trial
Official title:
A Prospective Multicenter Cohort Study Evaluating the Long Term Retention of Gadolinium in Human Bone and Skin After the Retrospective Administration of MultiHance or ProHance in Comparison With a Control Group Receiving No Exposure to Gadolinium
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).
Each subject enrolled will already be scheduled to undergo a hip, shoulder or knee
replacement, limb amputations or other orthopedic surgical procedures and each subject
enrolled in the non-control group will have retrospectively undergone one or more
administrations of MultiHance or PROHANCE with the last dose administered at least 1 month
before their scheduled surgery. In order to classify the subjects' renal status, the serum
creatinine (SCr) value and/or estimated glomerular filtration rate (eGFR) at the time of last
MRI with MultiHance or ProHance must be available and collected. The control subjects'
documented SCr values will be collected prior to enrollment in the study.
The bone and skin tissue sample(s) collected (during the subjects surgery) will be blinded to
gadolinium based contrast agent (GBCA) exposure and sent to a central laboratory where they
will be tested for gadolinium (Gd) and other analytes including calcium, phosphorous, sodium,
iron, zinc, and potassium. The Gd deposition of the resected bone and skin tissue will be
analyzed by Inductively Coupled Plasma Mass Spectroscopy (ICP-MS). The bone and skin tissue
will also be analyzed for other analytes using ICP-MS. These sample(s) will be stored at the
central laboratory.
A separate sample of the skin tissue collected (during the subjects' surgery) will also be
sent to a central dermatopathologist who will be blinded to GBCA exposure and test for any
possible NSF related abnormalities. These skin tissue sample(s) will be stored with the
central dermatopathology laboratory.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03337594 -
Gadolinium Retention in Human Bone Tissue in Pediatric Patients
|