A Prospective, Multicenter Observational Study to Evaluate Thyroid Function of Pediatric Subjects From Birth to 3 Years Exposed to ISOVUE® (Iopamidol Injection)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 4
- 主要终点
- Abnormal Thyroid Function
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
ISOVUE
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.
干预措施: Isovue (Drug)
结局指标
主要结局
Abnormal Thyroid Function
时间窗: 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.
次要结局
- 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))
- 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)