Long-Term Retention of Gadolinium in Bone

Condition: Nephrogenic Systemic Fibrosis

Eligibility

Key Inclusion Criteria

  • At least 18 years old
  • Scheduled for an orthopaedic surgical procedure
  • Scheduled to have sufficient bone removed during the orthopaedic surgical procedure and sufficient non-scarred skin tissue from the edge of the surgical incision or amputated part to permit sample collection

Key Exclusion Criteria

  • Has received different gadolinium contrast agents (GdCAs)
  • Has received intra-articular GdCA or per any other non-IV route
  • Has received any investigational product or has participated in any other clinical trial within 30 days prior to enrolling in this study

Full Study Name

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 (IRB no. 33020)

Summary

The purpose of this study is to further evaluate the safety of six commercially used gadolinium-containing contrast agents. In order to obtain a better view of internal organs, contrast agents containing gadolinium are often administered during magnetic resonance imaging. The screening procedure to be used will not evaluate any treatment but is a required first step to determine eligibility to enter the study. Participants will be asked to give permission for researchers to review their medical records. After the medical records are reviewed, patients will be informed whether they meet the requirements to participate in the rest of the study. If eligible, patients will be given more information about the study and can then decide if they would like to participate.

Researchers hope that this study will benefit individuals with renal impairment in need of magnetic resonance contrast imaging by helping determine whether gadolinium is related to a nephrogenic systemic fibrosis (NSF). NSF is an extremely rare disease predominantly reported in patients with severe kidney impairment, acute kidney insufficiency due to hepato-renal syndrome (kidney failure in patients with advanced chronic liver disease), or in patients with acute kidney insufficiency who have recently had or soon expect to have a liver transplantation.

Phase
Phase IV


Principal Investigator

Andrew Spitzer, MD

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