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Pediatric Risk of Hypothyroidism With Iodinated Contrast Media

NCT03631771 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2022-04-20

No results posted yet for this study

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

DRUG

Iohexol

Iohexol administered intravascularly

DRUG

Iodixanol

Iodixanol administered intravascularly

DRUG

Iopromide

Iopromide administered intravascularly

DRUG

Ioversol

Ioversol administered intravascularly

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Guerbet/Liebel-Flarsheim

    collaborator UNKNOWN

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Paul F. Sherwin, MD, PhD · GE Healthcare

  • Zuzana Jirakova Trnkova, MD, PhD · Bayer

  • Philippe Bourrinet, PharmD · Guerbet

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2024-08-31
Completion
2025-02-28
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03631771 on ClinicalTrials.gov