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 range

3 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The proportion of subjects who develop hypothyroidism post-ICM.

Timeframe: 6 months

Trial details

NCT IDNCT03631771

SponsorGE Healthcare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08

View on ClinicalTrials.gov More Hypothyroidism trials