AzTrials
AzTrials

HypothyroidismPhase 4NCT03631771

Pediatric Risk of Hypothyroidism With Iodinated Contrast Media

A Phase 4 study testing Iohexol, Iodixanol and Iopromide in people with Hypothyroidism, run by GE Healthcare.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages Up to 3 years
Conditions the study is for
Hypothyroidism
What is being tested?
Iohexol, Iodixanol and Iopromide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Mar 2022to Feb 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 3 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 9Show fewer
  • 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.

About this study

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

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
Being tested
Iohexol, Iodixanol, Iopromide, Ioversol
Keywords
Hypothyroidism, Child, Iodine, Iodinated contrast medium (ICM), Thyroid function test (TFT), Iodixanol, Iohexol, Iopromide, Ioversol
Medical subject headings
Hypothyroidism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IohexolDrug

    Also called Omnipaque™

    Iohexol administered intravascularly

  • IodixanolDrug

    Also called Visipaque™

    Iodixanol administered intravascularly

  • IopromideDrug

    Also called Ultravist®

    Iopromide administered intravascularly

  • IoversolDrug

    Also called Optiray®

    Ioversol administered intravascularly

Study groups in NCT03631771
Study groupRoleWhat they receive
Iodixanol, iohexol, iopromide, or ioversolExperimentalInvestigational 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.
Receives: Drug: Iohexol; Drug: Iodixanol; Drug: Iopromide; Drug: Ioversol

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months

Secondary outcomes (2)

  1. 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])

    Measured: 6 months

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2018
  2. Study startMar 2022 (estimated)
  3. Primary completionAug 2024 (estimated)
  4. Study completionFeb 2025 (estimated)

Why it 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

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03631771
Sponsor's protocol ID
GE-012-103/19476/OPY-44-002
Status last verified
Apr 2022
First submitted
13 Aug 2018
Last updated
20 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Iohexol, Iodixanol and Iopromide in people with Hypothyroidism, run by GE Healthcare.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of subjects who develop hypothyroidism post-ICM. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03631771.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in