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NCT03108378 · ClinicalTrials.gov registry record
Evaluation of Gd Retention in Human Bone and Skin After MultiHance or ProHance Administration Compared With Control
A clinical trial, sponsored by Bracco Diagnostics.
- Completed
- Registry status
- 28
- Enrollment target
NCT03108378: Completed study, sponsored by Bracco Diagnostics.
NCT03108378 is a clinical trial that has completed, run by Bracco Diagnostics. The registered enrollment target is 28 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03108378 has completed, sponsored by Bracco Diagnostics.
- COMPLETED
- Registry status
- 28 participants
- Enrollment target
Study Summary
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).
Primary Outcome
Determine the long-term gadolinium deposition in bone tissue and skin in subjects undergoing orthopedic surgery using Inductively Coupled Plasma Mass Spectroscopy (ICP-MS) in nmol gadolinium/g from surgically removed bone and skin.
Interventions
- PROCEDURE Surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2014-10 |
| Est. Completion | 2019-12 |
What the finished NCT03108378 record still lists
NCT03108378 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 28 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Surgery is the first listed.
NCT03108378 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03108378 about?
NCT03108378 is a clinical study titled "Evaluation of Gd Retention in Human Bone and Skin After MultiHance or ProHance Administration Compared With Control". 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 P...
What is the current status of trial NCT03108378?
This trial is currently completed. The enrollment target is 28 participants. The study started on 2014-10. Estimated completion is 2019-12.
What interventions are being tested in trial NCT03108378?
The interventions under investigation include: Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT03108378?
This trial is sponsored by Bracco Diagnostics, which has 37 total clinical trials registered on ClinicalTrials.gov.
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