Pediatric Risk of Hypothyroidism With Iodinated Contrast Media (NCT03631771) | Clinical Trial Compass
WithdrawnPhase 4
Pediatric Risk of Hypothyroidism With Iodinated Contrast Media
Stopped: It was determined that a study is no longer required because the clinical question posed by the study has been answered through published literature
0Started 2022-03
Plain-language summary
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.
Who can participate
Age range3 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 s…
What they're measuring
1
The proportion of subjects who develop hypothyroidism post-ICM.