Trials / Terminated

TerminatedNCT03779906

Thyroid Function of Pediatric Subjects Following Isovue® Administration

A Prospective, Multicenter Observational Study to Evaluate Thyroid Function of Pediatric Subjects From Birth to 3 Years Exposed to ISOVUE® (Iopamidol Injection)

Status: Terminated
Phase: Phase 4
Study type: Interventional
Enrollment: 17 (actual)

Sponsor: Bracco Diagnostics, Inc · Industry
Sex: All
Age: 3 Years
Healthy volunteers: Not accepted

Summary

This is a Phase IV prospective, multicenter, observational study to estimate the proportion of subjects 0 to 3 years of age who develop abnormal thyroid function after exposure to intravascular administration of ISOVUE for the required radiologic procedure as part of their standard of care.

Conditions

Hypothyroidism

Interventions

Type	Name	Description
DRUG	Isovue	Isovue will be given to all subjects per the standard of clinical care.

Timeline

Start date: 2019-03-26
Primary completion: 2021-11-15
Completion: 2022-03-25
First posted: 2018-12-19
Last updated: 2025-07-30
Results posted: 2025-07-30

Locations

4 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT03779906. Inclusion in this directory is not an endorsement.