Trials / Withdrawn
WithdrawnNCT03631771
Pediatric Risk of Hypothyroidism With Iodinated Contrast Media
A Multicenter, Prospective Study to Evaluate the Risk of Hypothyroidism in Pediatric Patients Administered Intravascular Iohexol, Iodixanol, Iopromide, or Ioversol. THYROPED.
- Status
- Withdrawn
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- GE Healthcare · Industry
- Sex
- All
- Age
- 3 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Iohexol | Iohexol administered intravascularly |
| DRUG | Iodixanol | Iodixanol administered intravascularly |
| DRUG | Iopromide | Iopromide administered intravascularly |
| DRUG | Ioversol | Ioversol administered intravascularly |
Timeline
- Start date
- 2022-03-01
- Primary completion
- 2024-08-01
- Completion
- 2025-02-01
- First posted
- 2018-08-15
- Last updated
- 2022-04-20
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03631771. Inclusion in this directory is not an endorsement.