Relationship Between Estimated Glomerular Filtration Rate and Biological Half-life of 131I. Prospective Analysis in Patients With Differentiated Thyroid Carcinoma.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Correlation between estimated renal function and biological half life of 131-I
研究概览
简要总结
Correlation analysis between estimated renal function and biological half life of 131-I during radioiodine treatment of patients with differentiated thyroid cancer.
详细描述
131-I during radioiodine treatment of patients with differentiated thyroid cancer is mainly renally excreted. It is advised in the clinical guidelines that serum creatinine should be determined before applying 131-I and if necessary the administered dose should be reduced. Nevertheless no guideline gives advice in what extent the dose should be decreased. The adjustment is at the discretion of the attending physician.
Aim of this prospective study is to correlate the biological half life of 131-I with the renal function to give objective recommendations concerning the reduction of the applied dose in patients with limited renal function.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •patients with differentiated thyroid carcinoma
- •stationary for treatment or diagnostic with radioiodine
- •state after thyroidectomy
- •written consent of the patient
- •minimum age 18 years
排除标准
- •no written consent of the patient
- •patients with large residual thyroid tissue (iodine uptake > 10%)
- •children under 18 years of age
- •inclusion in concurrent interventional studies
- •patients without TSH-stimulation by rhTSH
结局指标
主要结局
Correlation between estimated renal function and biological half life of 131-I
时间窗: 2 years
The estimated renal function (estimated GFR) is measured via determination of serum creatinine and Cystatin C. The biological half-life of I-131 is determined via whole-body dosimetry (whole-body probe and whole-body gamma camera) and blood probe measurement. Update 2017/06/07: After analyzing the preliminary results (based on the first 48 patients) probe measurements are not longer needed in a simplified study design. Additionally, measuring the creatinine concentration is no longer needed in comparison to the Cystatin C measurements.
次要结局
未报告次要终点