Gadolinium Retention in Human Bone Tissue in Pediatric Patients
The purpose of this study is to compare contrast agents, Dotarem or MultiHance. The study will test to see how much of these two contrast agents are deposited in the bones or tissues of pediatric patients. The patients receiving contrast will then be compared against pediatric patients who have not received any contrast prior to cardiac surgeries.
Conditions:
🦠 Gadolinium 🦠 MultiHance 🦠 Dotarem 🦠 Magnetic Resonance Imaging 🦠 Gadolinium Retention
🗓️ Study Start (Actual) 1 October 2017
🗓️ Primary Completion (Estimated) 31 August 2024
✅ Study Completion (Estimated) 1 September 2024
👥 Enrollment (Estimated) 60
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Charleston, South Carolina, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Female or male pediatric patient (patients aged newborn to 18 years old at the time of the MRI scan).
    • * Patients who require cardiac surgery for clinical purposes and meet one of the following three criteria:
    • 1. Patients who have undergone a routine contrast-enhanced MRI using MultiHance contrast agent only for clinical purposes.
    • 2. Patients who have undergone a routine contrast-enhanced MRI using Dotarem contrast agent only for clinical purposes.
    • 3. Patients who have not been exposed to gadolinium-based contrast agent administration

    Exclusion Criteria:

    • * Patient with abnormal renal function (defined as eGFR MDRD\<30 ml/min/1.73m2).
    • * Patient previously exposed to any other type of MRI gadolinium based contrast agent either at MUSC or at an outside facility
    • * Pregnant or breast feeding female patient
    • * Patient with a contraindication to MRI (e.g., pacemaker, aneurysm clip, severe claustrophobia, infusion pumps, cochlear implants metallic or others according to standard practice at MUSC).
Ages Eligible for Study: N/A to 18 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 6 November 2017
  • First Submitted that Met QC Criteria 6 November 2017
  • First Posted 9 November 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 July 2024
  • Last Update Posted 30 July 2024
  • Last Verified July 2024