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Evaluation of Gd Retention in Human Bone and Skin After MultiHance or ProHance Administration Compared With Control

NCT03108378 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 28

Last updated 2020-08-14

No results posted yet for this 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).

Conditions

  • Gadolinium Retention

Interventions

PROCEDURE

Surgery

hip, shoulder or knee replacement surgery, limb amputations or other orthopedic surgical procedures

Sponsors & Collaborators

  • Bracco Diagnostics, Inc

    lead INDUSTRY

Principal Investigators

  • Gianpaolo Pirovano, MD · Bracco Diagnostics, Inc

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03108378 on ClinicalTrials.gov