An Open, Single-arm, Self-controlled, Multi-center Phase 3 Study to Compare the Efficacy and Safety of rhTSH as An Adjunctive Diagnostic Tool in Differentiated Thyroid Cancer Patients Who Had Been Thyroidectomized Vs. Patients Who After Thyroid Hormone Withdrawal
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- the rate of concordant scans
研究概览
简要总结
This is A non-blinded trial. Oral radioiodine was given 24 hours after the second injection of rhTSH, and scanning was done 48 hours after the radioiodine administration. Each patient was scanned first following rhTSH and then scanned after thyroid hormone withdrawal.
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
- •Subjects voluntarily sign the informed consent form (ICF).
- •Age 18-75 years old, either male or female.
- •Patients with diagnosed differentiated papillary or follicular thyroid carcinoma, including papillary-follicular variant,.
- •Patients with a total or near-total thyroidectomy within 6 weeks prior to administered.
- •Low iodine diet for 4 weeks prior to randomized.
排除标准
- •Pregnant or breast feeding women.
- •Patients with other malignancies (exception for in situ cervix uterine cancer, baso cellular skin cancer or breast cancer in remission)
- •Subjects who are unsuitable to the trial in combination with other serious diseases, as identified by the investigator.
- •Subjects who have participated in another clinical trial of a new drug or medical instrument within 1 months before screening.
研究组 & 干预措施
rhTSH+Thyroid hormone withdrawal
rhTSH: rhTSH(0.9 mg) was administered intramuscularly (IM) once daily (qd) for 2 days. Twenty-four hours following the second dose of rhTSH.Oral radioiodine was given 24 hours after the second injection of rhTSH, and scanning was done 48 hours after the radioiodine administration.
Thyroid hormone withdrawal: Patients stop taking thyroid hormone for 14 days, and then monitor the level of thyroid stimulating hormone every week. When TSH>30mU/L, an ablative activity of 131I was administered.and scanning was done 48 hours after the radioiodine administration.
干预措施: rhTSH (Biological)
结局指标
主要结局
the rate of concordant scans
时间窗: 48 hours after the radioiodine administration
scan findings in agreement in a given patient using each preparation method
次要结局
未报告次要终点