[18F]Tetrafluoroborate PET/CT for the Detection of Differentiated Thyroid Cancer: A Phase II Imaging Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Optimal time kinetic point and number and localization of lymph node metastases + predictive 131I therapy response
研究概览
简要总结
a) To determine the optimal time point acquisition of [18F]TFB PET/CT, b) to determine the value of [18F]TFB PET/CT for detection of (pre-operative) metastatic lymph node(s) in patients with differentiated thyroid cancer and c) to determine the value of [18F]TFB PET/CT for the estimation of radioiodine therapy response in patients with persistent and recurrent differentiated thyroid cancer.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Group 1: patients with newly diagnosed differentiated thyroid cancer and pathologically proven lymph node metastases thyroid cancer referred for surgical resection - Group 2: patients with differentiated thyroid cancer referred for 131I therapy - The patient has provided written informed consent authorization before participating in the study - The patient is ≥ 18 years old - The patient has an ECOG status grade 0-2
排除标准
- •Patient is mentally or legally incapacitated - Patient is pregnant or lactating - Patient has been subjected to an excess of substrates of the sodium iodine symporter such as iodine (e.g. in the form of iodinated contrast agent) or perchlorate within the past 2 months. - Patient takes lithium - Patient takes amiodarone
结局指标
主要结局
Optimal time kinetic point and number and localization of lymph node metastases + predictive 131I therapy response
Optimal time kinetic point and number and localization of lymph node metastases + predictive 131I therapy response
Analysis of reference standards: ultrasonography, pathology and post-therapy 131I scan (these tests are performed under regular clinical care)
Analysis of reference standards: ultrasonography, pathology and post-therapy 131I scan (these tests are performed under regular clinical care)
次要结局
- To study [18F]TFB kinetics in normal thyroid tissue, in primary thyroid tumor tissue, in lymph node metastases and in distant metastases (SUVmax, tumorto-background ratio). - To analyse the possible correlation between [18F]TFB uptake and NISmembrane expression levels, as determined by immunohistochemistry. - To assess whether [18F]TFB PET/CT might be advisable especially for patients with minimally elevated tumor marker levels.
研究者
Prof. dr. Frederik Verburg
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)