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Thyroid Function of Pediatric Subjects Following Isovue® Administration

Primary Purpose

Hypothyroidism

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Isovue
Sponsored by
Bracco Diagnostics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypothyroidism focused on measuring hypothyroidism, ISOVUE, Iodinated Contrast Agent

Eligibility Criteria

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

Inclusion Criteria:

  • Is male or female from 0 to 3 years of age;
  • Is scheduled to undergo a radiologic examination that requires intravascular administration of ISOVUE as part of his/her standard of care;
  • Has normal baseline thyroid function tests (TSH, total T3, total T4, and fT4) performed at a local laboratory with blood sample obtained within one week prior to ISOVUE administration;
  • Written informed consent is obtained from the subject's parent(s) or legally acceptable representative(s) (according to local regulations) who are willing to comply with the protocol requirements.

Exclusion Criteria:

  • Has any known allergy to one or more of the ingredients of ISOVUE;
  • Has been diagnosed with congenital hypothyroidism;
  • Has undergone radiation treatments to the head or neck;
  • Is currently on thyroid replacement therapy;
  • Is on therapy with dopamine or any treatment which may affect the thyroid function testing results;
  • Has been exposed to any topical iodinated product within 30 days prior to enrollment in the present study;
  • Has been exposed to an iodinated contrast agent within 1 year prior to enrollment in the present study, including any administration of iodinated contrast agents during placement of a central line;
  • Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.

Sites / Locations

  • Children's Hospital and Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ISOVUE

Arm Description

Isovue will be given to all subjects per the standard of clinical care.The specific iodine concentration and volume of ISOVUE used during the radiologic procedure will depend on the type of procedure and the standards in place at the site where the procedure is performed.

Outcomes

Primary Outcome Measures

Abnormal thyroid function
The primary outcome of this study is to evaluate the proportion of subjects, 0 to 3 years of age, developing abnormal thyroid function after administration of ISOVUE.

Secondary Outcome Measures

Hypothyroidism
To evaluate the proportion of subjects, 0 to 3 years of age, with hypothyroidism regardless of the need for thyroid hormone therapy after administration of ISOVUE.
Thyroid hormone replacement therapy
The proportion of subjects initiated on thyroid hormone replacement therapy.

Full Information

First Posted
December 17, 2018
Last Updated
July 27, 2023
Sponsor
Bracco Diagnostics, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03779906
Brief Title
Thyroid Function of Pediatric Subjects Following Isovue® Administration
Official Title
A Prospective, Multicenter Observational Study to Evaluate Thyroid Function of Pediatric Subjects From Birth to 3 Years Exposed to ISOVUE® (Iopamidol Injection)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 26, 2019 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bracco Diagnostics, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothyroidism
Keywords
hypothyroidism, ISOVUE, Iodinated Contrast Agent

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1560 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ISOVUE
Arm Type
Experimental
Arm Description
Isovue will be given to all subjects per the standard of clinical care.The specific iodine concentration and volume of ISOVUE used during the radiologic procedure will depend on the type of procedure and the standards in place at the site where the procedure is performed.
Intervention Type
Drug
Intervention Name(s)
Isovue
Other Intervention Name(s)
IOPAMIDOL injection
Intervention Description
Isovue will be given to all subjects per the standard of clinical care.
Primary Outcome Measure Information:
Title
Abnormal thyroid function
Description
The primary outcome of this study is to evaluate the proportion of subjects, 0 to 3 years of age, developing abnormal thyroid function after administration of ISOVUE.
Time Frame
Day 1 to 2 months
Secondary Outcome Measure Information:
Title
Hypothyroidism
Description
To evaluate the proportion of subjects, 0 to 3 years of age, with hypothyroidism regardless of the need for thyroid hormone therapy after administration of ISOVUE.
Time Frame
Day 1 to 2 months
Title
Thyroid hormone replacement therapy
Description
The proportion of subjects initiated on thyroid hormone replacement therapy.
Time Frame
Day 1 to 12 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is male or female from 0 to 3 years of age; Is scheduled to undergo a radiologic examination that requires intravascular administration of ISOVUE as part of his/her standard of care; Has normal baseline thyroid function tests (TSH, total T3, total T4, and fT4) performed at a local laboratory with blood sample obtained within one week prior to ISOVUE administration; Written informed consent is obtained from the subject's parent(s) or legally acceptable representative(s) (according to local regulations) who are willing to comply with the protocol requirements. Exclusion Criteria: Has any known allergy to one or more of the ingredients of ISOVUE; Has been diagnosed with congenital hypothyroidism; Has undergone radiation treatments to the head or neck; Is currently on thyroid replacement therapy; Is on therapy with dopamine or any treatment which may affect the thyroid function testing results; Has been exposed to any topical iodinated product within 30 days prior to enrollment in the present study; Has been exposed to an iodinated contrast agent within 1 year prior to enrollment in the present study, including any administration of iodinated contrast agents during placement of a central line; Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Luigia Storto, MD
Organizational Affiliation
Bracco Corporate
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital and Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States

12. IPD Sharing Statement

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Thyroid Function of Pediatric Subjects Following Isovue® Administration

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