Hypothyroidism
Conditions
Keywords
hypothyroidism, ISOVUE, Iodinated Contrast Agent
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.
Interventions
DRUGIsovue
Isovue will be given to all subjects per the standard of clinical care.
Sponsors
Bracco Diagnostics, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abnormal Thyroid Function | Day 1 (day dosed with intravascular administration of ISOVUE as part of their standard of care examination) to 1-month follow-up or 2-month follow-up | The primary outcome of this study was to evaluate the proportion of subjects, 0 to 3 years of age, with abnormal TSH values post-baseline following administration of ISOVUE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypothyroidism | Day 1 (day dosed with intravascular administration of ISOVUE as part of their standard of care examination) to 1-month follow-up or 2-month follow-up | 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 | Day 1 (day dosed with intravascular administration of ISOVUE as part of their standard of care examination) to 1-month follow-up or 2-month follow-up to 6- to 12 months follow-up (if applicable) | The proportion of subjects initiated on thyroid hormone replacement therapy. |
Countries
United States
Participant flow
Recruitment details
On 03 March 2022, Food and Drug Administration (FDA) released Bracco from the Post-Marketing Requirement (PMR) commitment as the risk of thyroid dysfunction was adequately addressed by FDA's review of findings reported in currently available publications. Therefore, the study was terminated on 25 March 2022 with only 17 subjects enrolled and dosed.
Pre-assignment details
Pediatric subjects (0-3 years of age) scheduled to undergo a routine radiologic procedure with intravascular administration of ISOVUE who had normal TFTs (serum TSH, T3, T4 & fT4) at baseline were to be enrolled. TFTs were to be reassessed at 1 month and 2 months post-ISOVUE injection. If TSH values were abnormal at 1- or 2-months, follow-up (via pre-defined questionnaire) was required at 6 and 12 months to monitor subject's progress (if any). Efficacy of ISOVUE was not assessed.
Participants by arm
| Arm | Count |
|---|---|
| ISOVUE Intravascular administration of ISOVUE as part of the subject's standard of care examination. | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | COVID pandemic | 1 |
| Overall Study | Lost to Follow-up | 7 |
Baseline characteristics
| Characteristic | ISOVUE |
|---|---|
| Age, Customized Above 65 years | 0 Participants |
| Age, Customized Between 0 to 3 years | 17 Participants |
| Age, Customized Between 18 and 65 years | 0 Participants |
| Age, Customized Between 4 to 17 years | 0 Participants |
| Number of Subjects with TFTs at Baseline Abnormal | 0 Participants |
| Number of Subjects with TFTs at Baseline Normal | 17 Participants |
| Race/Ethnicity, Customized Black | 2 Participants |
| Race/Ethnicity, Customized Latino | 1 Participants |
| Race/Ethnicity, Customized More than one race | 1 Participants |
| Race/Ethnicity, Customized White | 13 Participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 1 / 17 |
Outcome results
Primary
Abnormal Thyroid Function
The primary outcome of this study was to evaluate the proportion of subjects, 0 to 3 years of age, with abnormal TSH values post-baseline following administration of ISOVUE.
Time frame: Day 1 (day dosed with intravascular administration of ISOVUE as part of their standard of care examination) to 1-month follow-up or 2-month follow-up
Population: Number of subjects evaluated for TFTs at baseline and post-baseline following intravascular administration of ISOVUE.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ISOVUE | Abnormal Thyroid Function | Number of Patients with Abnormal TSH only at 1-month follow-up | 0 Participants |
| ISOVUE | Abnormal Thyroid Function | Number of Patients with Abnormal TSH only at 2-month follow-up | 0 Participants |
| ISOVUE | Abnormal Thyroid Function | Number of Patients with Abnormal TSH at 1 and 2 months' follow-up | 0 Participants |
| ISOVUE | Abnormal Thyroid Function | Number of Patients with Normal TSH at All Follow-up Timepoints | 17 Participants |
Secondary
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.
Time frame: Day 1 (day dosed with intravascular administration of ISOVUE as part of their standard of care examination) to 1-month follow-up or 2-month follow-up
Population: Number of subjects evaluated for TFTs at baseline and post-baseline following intravascular administration of ISOVUE.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ISOVUE | Hypothyroidism | Number of subjects with hypothyroidism at 1-month follow-up | 0 Participants |
| ISOVUE | Hypothyroidism | Number of subjects with hypothyroidism at 2-month follow-up | 0 Participants |
| ISOVUE | Hypothyroidism | Number of subjects with normal thyroid values through 2-month follow-up | 17 Participants |
Secondary
Thyroid Hormone Replacement Therapy
The proportion of subjects initiated on thyroid hormone replacement therapy.
Time frame: Day 1 (day dosed with intravascular administration of ISOVUE as part of their standard of care examination) to 1-month follow-up or 2-month follow-up to 6- to 12 months follow-up (if applicable)
Population: Number of subjects evaluated for TFTs at baseline and post-baseline following intravascular administration of ISOVUE.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ISOVUE | Thyroid Hormone Replacement Therapy | Number of subjects who started hormone therapy by 1-month follow-up | 0 Participants |
| ISOVUE | Thyroid Hormone Replacement Therapy | Number of subjects who started hormone therapy by 2-month follow-up | 0 Participants |
| ISOVUE | Thyroid Hormone Replacement Therapy | Number of subjects who did not start hormone therapy through 2-month follow-up | 17 Participants |
| ISOVUE | Thyroid Hormone Replacement Therapy | Number of subjects who started hormone therapy by 6- or 12-month follow-up | NA Participants |