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Pediatric Risk of Hypothyroidism With Iodinated Contrast Media

Primary Purpose

Hypothyroidism

Status

Withdrawn

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Iohexol

Iodixanol

Iopromide

Ioversol

About this trial

This is an interventional other trial for Hypothyroidism focused on measuring Hypothyroidism, Child, Iodine, Iodinated contrast medium (ICM), Thyroid function test (TFT), Iodixanol, Iohexol, Iopromide, Ioversol

Eligibility Criteria

undefined - 3 Years (Child)All SexesDoes not accept healthy volunteers

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 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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Iodixanol, iohexol, iopromide, or ioversol

Arm Description

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.

Outcomes

Primary Outcome Measures

The proportion of subjects who develop hypothyroidism post-ICM.

Secondary Outcome Measures

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])

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

Full Information

NCT ID

NCT03631771

First Posted

August 13, 2018

Last Updated

April 13, 2022

Sponsor

GE Healthcare

Collaborators

Bayer, Guerbet/Liebel-Flarsheim

1. Study Identification

Unique Protocol Identification Number

NCT03631771

Brief Title

Pediatric Risk of Hypothyroidism With Iodinated Contrast Media

Official Title

A Multicenter, Prospective Study to Evaluate the Risk of Hypothyroidism in Pediatric Patients Administered Intravascular Iohexol, Iodixanol, Iopromide, or Ioversol. THYROPED.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Withdrawn

Why 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

Study Start Date

March 2022 (Anticipated)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GE Healthcare

Collaborators

Bayer, Guerbet/Liebel-Flarsheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypothyroidism

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Iodixanol, iohexol, iopromide, or ioversol

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Iohexol

Other Intervention Name(s)

Omnipaque™

Intervention Description

Iohexol administered intravascularly

Intervention Type

Drug

Intervention Name(s)

Iodixanol

Other Intervention Name(s)

Visipaque™

Intervention Description

Iodixanol administered intravascularly

Intervention Type

Drug

Intervention Name(s)

Iopromide

Other Intervention Name(s)

Ultravist®

Intervention Description

Iopromide administered intravascularly

Intervention Type

Drug

Intervention Name(s)

Ioversol

Other Intervention Name(s)

Optiray®

Intervention Description

Ioversol administered intravascularly

Primary Outcome Measure Information:

Title

The proportion of subjects who develop hypothyroidism post-ICM.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Time Frame

6 months

Title

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

Time Frame

6 months

10. Eligibility

Sex

All

Maximum Age & Unit of Time

3 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul F. Sherwin, MD, PhD

Organizational Affiliation

GE Healthcare

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Zuzana Jirakova Trnkova, MD, PhD

Organizational Affiliation

Bayer

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Philippe Bourrinet, PharmD

Organizational Affiliation

Guerbet

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Pediatric Risk of Hypothyroidism With Iodinated Contrast Media

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