The Uptake of Radioactive Iodine Before and After a Low Iodine Diet in Patients With Differentiated Thyroid Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Iodine uptake
研究概览
简要总结
The goal of this clinical trial is to compare the difference in thyroid uptake of a low dose radioactive iodine (10 MBq 123-I or 37 MBq 123-I) in athyreotic patients with differentiated thyroid carcinoma before and after a low iodine diet (LID) of 7 days.
The main question it aims to answer is:
• What is the difference in iodine uptake before and after a LID of 7 days?
Uptake of a low dose of 123-iodine will be measured in participants before and after a low iodine diet of 7 days. Researchers will compare the uptake (%) before and after the LID.
详细描述
Rationale:
Differentiated thyroid carcinoma (DTC) is the most common form of thyroid cancer. The initial treatment of DTC consists of a total thyroidectomy followed by ablation therapy with radioactive iodine (131I) which destroy residual thyroid (cancer) tissue. Before starting the (ablation) therapy with 131I, patients have to follow a low iodine diet (LID) reducing the iodine intake < 50 mcg per day. Depleting the overall iodine store in the body theoretically maximizes the expression of the sodium-iodine symporter (NIS). This increased NIS expression results in an increase of the uptake of 131I in remaining thyroid (cancer) cells during 131I therapy and therefore improves the ablation success rates. However, there is no prospective data to support this, merely some retrospective contradictionary data. Patients experience the strict adherence to LID as stressful, distasteful and overwhelming in combination with a new diagnosis of cancer and withdrawal from thyroid hormone. Besides, they are afraid to apply the LID inadequately, which complicates achieving a balanced diet, essential in cancer recovery.
Objective:
To compare the difference in thyroid uptake of a low dose radioactive iodine (10 MBq 123I or 37 MBq 123I), in DTC patients after thyroidectomy, before and after a LID of 7 days.
Study design: observational, single center study performed in the University Medical Center Groningen (UMCG) Groningen, the Netherlands.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, men and women above the age of 18 years, have to be diagnosed with DTC and have to follow a LID prior to the 131I ablation therapy according to the Dutch DTC guideline
- •Patients have to be fit to adhere to the study protocol
- •Patients have to be able to read and understand the Dutch language
排除标准
- •Age < 18 years
- •Patients using amiodarone
- •Patients receiving iodinated contrast < 3 months before the LID
- •Pregnancy
- •Patients prepared for ablation therapy with rhTSH
- •Renal impairment, EGFR <30ml/min/1,73m2
研究组 & 干预措施
Low iodine diet
Patients recieve a low iodine diet. Consecutive iodine uptake measurements will be made before and after starting this low iodine diet. This study is constructed of only one study arm, and patients will be compared to themselves.
干预措施: Low iodine diet (Behavioral)
结局指标
主要结局
Iodine uptake
时间窗: 7 days
Difference in iodine uptake in percentage
次要结局
未报告次要终点