This is a Phase 4 multicenter prospective study to estimate the proportion of patients aged birth to 3 years who develop hypothyroidism within 6 months after receiving intravascular iohexol (Omnipaque™), iodixanol (Visipaque™), iopromide (Ultravist®), or ioversol (Optiray®) as the iodinated contrast medium (ICM) for clinical evaluation during an ICM-enhanced diagnostic imaging procedure.
Full Title of Study: “A Multicenter, Prospective Study to Evaluate the Risk of Hypothyroidism in Pediatric Patients Administered Intravascular Iohexol, Iodixanol, Iopromide, or Ioversol. THYROPED.”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Other
- Masking: None (Open Label)
- Study Primary Completion Date: August 2024
- Drug: Iohexol
- Iohexol administered intravascularly
- Drug: Iodixanol
- Iodixanol administered intravascularly
- Drug: Iopromide
- Iopromide administered intravascularly
- Drug: Ioversol
- Ioversol administered intravascularly
Arms, Groups and Cohorts
- Experimental: Iodixanol, iohexol, iopromide, or ioversol
- Investigational medicinal product administered intravascularly per usual clinical practice at each participating institution. Doses will be per usual practice. The dose of ICM, timing of ICM administration in relation to the diagnostic procedure, rate of ICM administration, and route of ICM administration will be determined by the physician performing the enhanced radiologic procedure per medical need and local clinical practice.
Clinical Trial Outcome Measures
- The proportion of subjects who develop hypothyroidism post-ICM.
- Time Frame: 6 months
- Proportion of subjects with changes from baseline in thyroid function tests that exceed the available literature-reported reference change values for these parameters (ca. >60% for TSH and >30% for thyroxine [T4]; [Chaler et al 2012])
- Time Frame: 6 months
- Proportion of subjects with abnormal thyroid function tests at each time point.
- Time Frame: 6 months
Participating in This Clinical Trial
- Male and female patients aged birth to 3 years who, as part of the standard of care in the clinical practice of medicine, are referred to and will undergo a radiographic diagnostic imaging procedure that uses intravascularly administered iohexol (Omnipaque™), iodixanol (Visipaque™), iopromide (Ultravist®), or ioversol (Optiray®) as the ICM for contrast enhancement.
- Written informed consent has been given for the patient by one or more parents or other legally acceptable representatives, as required by local regulations and laws.
- When applicable (neonates), the patient's biological mother consents to providing information about her medical history and medication usage.
- The patient has normal pre-procedure (screening) serum TFTs (TSH, TT4, FT4, TT3), TSI, and urine (UI/UCr).
- The patient's pre-procedure (screening) serum chemistry is either normal or not clinically significantly abnormal.
- The patient has normal pre-procedure (screening) eGFR for age by the revised Schwartz formula [Schwartz et al 2009].
- The patient's parent(s) or other legally acceptable representative(s) is/are able and willing to comply with the study schedule and procedures.
- The planned radiographic procedure is part of a clinical research study rather than clinical practice.
- The patient has known or suspected thyroid disease, Down syndrome (trisomy 21), or Type 1 diabetes.
- The patient currently receives thyroid hormone replacement therapy, or such therapy is planned or being considered.
- The patient has been exposed to thyroid protection for imaging procedures, within the last 6 months or such procedure is planned or being considered.
- The patient currently receives one or more anti-thyroid medications, or such therapy is planned or being considered.
- The patient has known or suspected past or present exposure to thyroid suppressants, including but not limited to drugs (e.g., amiodarone), inorganic iodide (potassium iodide, sodium iodide, etc.), perchlorate, thiocyanate, nitrate, lithium, and topical iodine disinfectant (e.g., povidone-iodine).
- The patient has undergone (or is expected to undergo during the study) radiation treatments to the head or neck.
- There is a high likelihood that the patient will undergo surgery or more than one ICM-enhanced procedure in the following 10 weeks.
- The patient has a history of hypersensitivity to ICM or any components, or a history of a severe cutaneous adverse reaction to ICM.
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: 3 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- GE Healthcare
- Provider of Information About this Clinical Study
- Overall Official(s)
- Paul F. Sherwin, MD, PhD, Study Director, GE Healthcare
- Thomas Balzer, MD, Study Director, Bayer
- Philippe Bourrinet, PharmD, Study Director, Guerbet
- Overall Contact(s)
- GEHC Clinical Trials Contact, +44 (0) 1494 543915, Jay.Chahal@ge.com
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