Pediatric Risk of Hypothyroidism With Iodinated Contrast Media

NCT03631771 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: GE-012-103/19476/OPY-44-002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Hypothyroidism

Keywords

Hypothyroidism; Child; Iodine; Iodinated contrast medium (ICM); Thyroid function test (TFT); Iodixanol; Iohexol; Iopromide; Ioversol

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects who develop hypothyroidism post-ICM.

  6 months

Secondary Outcomes (2)

• Proportion of subjects with changes from baseline in thyroid function tests that exceed the available literature-reported reference change values for these parameters (ca. >60% for TSH and >30% for thyroxine [T4]; [Chaler et al 2012])

  6 months

• Proportion of subjects with abnormal thyroid function tests at each time point.

  6 months

Study Arms (1)

Iodixanol, iohexol, iopromide, or ioversol

EXPERIMENTAL

Investigational medicinal product administered intravascularly per usual clinical practice at each participating institution. Doses will be per usual practice. The dose of ICM, timing of ICM administration in relation to the diagnostic procedure, rate of ICM administration, and route of ICM administration will be determined by the physician performing the enhanced radiologic procedure per medical need and local clinical practice.

Drug: Iohexol; Drug: Iodixanol; Drug: Iopromide; Drug: Ioversol

Interventions

Iohexol DRUG

Iohexol administered intravascularly

Also known as: Omnipaque™

Iodixanol, iohexol, iopromide, or ioversol

Iodixanol DRUG

Iodixanol administered intravascularly

Also known as: Visipaque™

Iodixanol, iohexol, iopromide, or ioversol

Iopromide DRUG

Iopromide administered intravascularly

Also known as: Ultravist®

Iodixanol, iohexol, iopromide, or ioversol

Ioversol DRUG

Ioversol administered intravascularly

Also known as: Optiray®

Iodixanol, iohexol, iopromide, or ioversol

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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 such therapy is planned or being considered.
• The patient has been exposed to thyroid protection for imaging procedures, within the last 6 months or such procedure is planned or being considered.
• The patient currently receives one or more anti-thyroid medications, or such therapy is planned or being considered.
• The patient has known or suspected past or present exposure to thyroid suppressants, including but not limited to drugs (e.g., amiodarone), inorganic iodide (potassium iodide, sodium iodide, etc.), perchlorate, thiocyanate, nitrate, lithium, and topical iodine disinfectant (e.g., povidone-iodine).
• The patient has undergone (or is expected to undergo during the study) radiation treatments to the head or neck.
• There is a high likelihood that the patient will undergo surgery or more than one ICM-enhanced procedure in the following 10 weeks.
• The patient has a history of hypersensitivity to ICM or any components, or a history of a severe cutaneous adverse reaction to ICM.

Sponsors & Collaborators

• GE Healthcare: lead
• Bayer: collaborator
• Guerbet/Liebel-Flarsheim: collaborator

MeSH Terms

Conditions

Hypothyroidism

Interventions

Iohexol; iodixanol; iopromide; ioversol

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Paul F. Sherwin, MD, PhD

  GE Healthcare

  STUDY DIRECTOR

• Zuzana Jirakova Trnkova, MD, PhD

  Bayer

  STUDY DIRECTOR

• Philippe Bourrinet, PharmD

  Guerbet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 15, 2018
• Study Start: March 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: February 1, 2025
• Last Updated: April 20, 2022

Record last verified: 2022-04