Trial Outcomes & Findings for Thyroid Function of Pediatric Subjects Following Isovue® Administration (NCT NCT03779906)

NCT ID: NCT03779906

Last Updated: 2025-07-30

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 17 participants
• Primary outcome timeframe: 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
• Results posted on: 2025-07-30

Participant Flow

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.

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.

Participant milestones

Measure	ISOVUE Intravascular administration of ISOVUE as part of the subject's standard of care examination.
Overall Study STARTED	17
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	ISOVUE Intravascular administration of ISOVUE as part of the subject's standard of care examination.
Overall Study Lost to Follow-up	7
Overall Study COVID pandemic	1

Baseline Characteristics

Thyroid Function of Pediatric Subjects Following Isovue® Administration

Baseline characteristics by cohort

Measure	ISOVUE n=17 Participants Intravascular administration of ISOVUE as part of the subject's standard of care examination.
Age, Customized Between 0 to 3 years	17 Participants n=5 Participants
Age, Customized Between 4 to 17 years	0 Participants n=5 Participants
Age, Customized Between 18 and 65 years	0 Participants n=5 Participants
Age, Customized Above 65 years	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race/Ethnicity, Customized White	13 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants
Race/Ethnicity, Customized Latino	1 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	1 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants
Number of Subjects with TFTs at Baseline Normal	17 Participants n=5 Participants
Number of Subjects with TFTs at Baseline Abnormal	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	ISOVUE n=17 Participants Intravascular administration of ISOVUE as part of a subject's standard of care examination.
Abnormal Thyroid Function Number of Patients with Abnormal TSH only at 1-month follow-up	0 Participants
Abnormal Thyroid Function Number of Patients with Abnormal TSH only at 2-month follow-up	0 Participants
Abnormal Thyroid Function Number of Patients with Abnormal TSH at 1 and 2 months' follow-up	0 Participants
Abnormal Thyroid Function Number of Patients with Normal TSH at All Follow-up Timepoints	17 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	ISOVUE n=17 Participants Intravascular administration of ISOVUE as part of a subject's standard of care examination.
Hypothyroidism Number of subjects with hypothyroidism at 1-month follow-up	0 Participants
Hypothyroidism Number of subjects with hypothyroidism at 2-month follow-up	0 Participants
Hypothyroidism Number of subjects with normal thyroid values through 2-month follow-up	17 Participants

SECONDARY outcome

Timeframe: 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.

The proportion of subjects initiated on thyroid hormone replacement therapy.

Outcome measures

Measure	ISOVUE n=17 Participants Intravascular administration of ISOVUE as part of a subject's standard of care examination.
Thyroid Hormone Replacement Therapy Number of subjects who started hormone therapy by 6- or 12-month follow-up	NA Participants Subjects were not further evaluated at 6 and 12 months if there were no abnormal TSH values at 1 and/or 2 months follow-up.
Thyroid Hormone Replacement Therapy Number of subjects who started hormone therapy by 1-month follow-up	0 Participants
Thyroid Hormone Replacement Therapy Number of subjects who started hormone therapy by 2-month follow-up	0 Participants
Thyroid Hormone Replacement Therapy Number of subjects who did not start hormone therapy through 2-month follow-up	17 Participants

Adverse Events

ISOVUE

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure

ISOVUE n=17 participants at risk Intravascular administration of ISOVUE as part of a subject's standard of care examination.

General disorders Pyrexia

5.9% 1/17 • Number of events 1 • As this was an Observational Study, untoward medical occurrences (i.e., adverse events) were monitored through completion of the exam with administration of ISOVUE, up to 1 week for subjects dosed as part of their routine standard of care. Subjects were monitored for any untoward medical occurrences from the time of signed Informed Consent through the timeframe associated with the investigational medicinal product administration. All untoward medical occurrences were recorded in the Adverse Event section of the CRF.

Other adverse events

Adverse event data not reported

Additional Information

Maria Luigia Storto, MD, Executive Director Medical Planning and Management X-ray products

Bracco Diagnostics Inc.

Phone: 609-514-2262

Email: MariaLuigia.Storto@diag.bracco.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place