Efficacy of Empirical Radioactive Iodine Therapy in Differentiated Thyroid Carcinoma Patients With Thyroglobulin Elevation Negative Iodine Scintigraphy (TENIS) Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- efficacy of empirical radioactive iodine therapy
研究概览
简要总结
The aim of the study is assessment the efficacy of empiric RAI therapy in DTC patients with elevated thyroglobulin levels and negative iodine scintigraphy.
详细描述
Thyroid cancer is the most common endocrine malignancy. Differentiated thyroid cancer (DTC) accounting for more than 90% of all thyroid cancers.
The standard treatment of patients with (DTC) consists of surgery followed by radioactive iodine therapy (RAI).The response to initial therapy is usually assessed by serum thyroglobulin (Tg) levels and neck ultrasonography (US) according to American Thyroid Association (ATA) guidelines.
Some patients with elevated serum Tg levels don't not show evidence of structural disease during follow up.
Diagnostic iodine-131 (131I) whole body scan (WBS) has been largely used for assessment of disease status.
Empiric RAI administration can be considered in patients with elevated Tg values after the first treatment and without evidence of structural disease (negative iodine scintigraphy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Masking Description
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This study will include adult patients with pathologically proved DTC who underwent total thyroidectomy and received RAI therapy presented to our nuclear medicine unit with evidence of persistent or recurrent biochemical disease during follow up.
排除标准
- •Undifferentiated thyroid cancer.
- •Patients with evidence of structural disease.
- •Patients less than 18 years old.
研究组 & 干预措施
patients received empirical dose of RAI
patients treated with empirical dose
干预措施: Radioactive Iodine Therapy (Drug)
patients didn't receive empirical dose of RAI
patients monitored without empirical RAI dose
结局指标
主要结局
efficacy of empirical radioactive iodine therapy
时间窗: 2 years
by assessment of tumor marker (serum thyroglobulin ) if decreased after empirical therapy
次要结局
未报告次要终点
研究者
Mona Nabil Helbawi
principal investigator
Assiut University