Prospective, Single-centre, Feasibility Study to Evaluate the Use of 18F-PSMA PET/CT in Patients With Biochemically Active Medullary Thyroid Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Sensitivity of 18F-PSMA PET/CT for medullary thyroid cancer.
研究概览
简要总结
Rationale: In patients with medullary thyroid cancer (MTC), molecular imaging is used to assess the extent of disease in the primary diagnostic process and follow-up period to determine possible therapeutic options. The currently most used tracer in clinical practice, F-18 labelled fluorodeoxyglucose (18F-FDG), does not accurately detect MTC tumors with an indolent growth rate. A new, complimentary tracer is warranted to detect different subtypes.
Objective: The primary objective is to assess the feasibility of using the F-18 labelled prostate specific membrane antigen (18F-PSMA) PET/CT for (re)staging patients with medullary thyroid cancer. The secondary objective is to compare the ability to detect MTC with the 18F-PSMA PET/CT to that of the 18F-FDG PET/CT.
Study design: Prospective, single-centre, feasibility study.
Study population: Patients (18 years of age or older) with biochemically and cytological/histological confirmed MTC, for whom the indication of an 18F-FDG PET/CT for tumor staging has already been determined on clinical grounds.
Main study parameters/endpoints: The primary outcome of this study is the performance (lesion-based//patient-based sensitivity) of the 18F-PSMA PET to detect MTC lesions in patients with cytologically/histologically confirmed disease. Secondarily, the performance of the 18F-PSMA PET will be compared to the 18F-FDG PET/CT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •18 years of age or older
- •Histological or cytological proven MTC
- •Biochemical evidence of disease activity (elevated/increasing calcitonin and/or CEA)
- •Clinical indication for an 18F-FDG PET/CT
- •Able to follow instructions to participate in the study
- •Able to give informed consent
排除标准
- •Patients with prostate cancer or renal cell carcinoma
- •Pregnant patients
- •Recent neck surgery (<3 months ago)
研究组 & 干预措施
Patients with Medullary Thyroid Cancer undergoing 18F-PSMA PET/CT
Only 1 arm exists in this study.
Patients with Medullary Thyroid Cancer undergo a PET/CT after receiving the Fluorine-18 labeled prostate specific membrane antigen (18F-PSMA-1007) tracer intravenously. Each patient will undergo this process one time. Patients will receive 3 MBq/kg (+- 10%) in 8,3 ml (maximum 400 MBq). Waiting time after injection is 60 minutes. Scanning time is approximately 45 minutes.
干预措施: 18F-PSMA-1007 (Drug)
结局指标
主要结局
Sensitivity of 18F-PSMA PET/CT for medullary thyroid cancer.
时间窗: Up to 2 years
Patient- and lesion-based sensitivity.
次要结局
- Comparison of the performance of the 18F-PSMA PET/CT to a clinically performed 18F-FDG PET/CT.(Up to 2 years)
- Correlation between 18F-PSMA uptake in tumor lesions and serum calcitonin values.(Up to 2 years)
- Correlation between 18F-PSMA uptake in tumor lesions and serum carcinoembryonic antigen (CEA) values.(Up to 2 years)
- Correlation between 18F-FDG uptake in tumor lesions and serum carcinoembryonic antigen (CEA) values.(Up to 2 years)
- Correlation between 18F-FDG uptake in tumor lesions and serum calcitonin values.(Up to 2 years)