Potential of uEXPLORER Total-body PET/CT in Nasopharyngeal Carcinoma: The Dynamic Imaging, Kinetic Parameters, and Comparison With Conventional PET/CT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- The results of uEXPLORER Total-body PET/CT
研究概览
简要总结
uEXPLORER total-body PET/CT in Nasopharyngeal Carcinoma
详细描述
A 194-cm-long total-body positron emission tomography/computed tomography (PET/CT) scanner (uEXPLORER), has been constructed to offer a transformative platform for human radiotracer imaging in clinical research and healthcare. The objective of this study is to determine its specific effect in newly diagnosed nasopharyngeal carcinoma compared with conventional PET/CT and the quantitative kinetic parameters including glucose metabolic rate (Ki), glucose transport rate of flow-in (k1) and flow-out (k2) between tissue and blood, and glucosamine-6-phosphatization rate in tissue (k3). All the neck lymph nodes suspected for metastatic in PET/CT were biopsied under the guidance of ultrasound for a pathological diagnosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be informed of the investigational nature of this study and given written informed consent.
- •Aged between 18-65, male/female.
- •Histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, WHO II and III)..
- •Fertile women should practice contraception during the study period.
- •HGB ≥90g/L ,WBC ≥4*109/L , PLT ≥100*109/L,
- •With normal liver function test (ALT and AST ≤2.5*ULN, TBil ≤2.0*ULN)
- •With normal renal function test (serum creatinine ≤1.5*ULN)
排除标准
- •Women in pregnancy or lactation
- •Patients with diabetes
- •Prior malignancy except adequately treated basal cell, squamous cell skin cancer, or cervical cancer in situ.
- •Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.
- •Already involved in other clinical trial.
- •Mental disorder, civil disability, limited capacity for civil conduct.
结局指标
主要结局
The results of uEXPLORER Total-body PET/CT
时间窗: 6 months
The Dynamic Imaging, Kinetic Parameters of uEXPLORER Total-body PET/CT
次要结局
- Protocol of TB-PET/CT in NPC(6 months)
- Comparison of uEXPLORER Total-body PET/CT and Conventional PET/CT(6 months)
研究者
Hai-Qiang Mai,MD,PhD
Chief Physician
Sun Yat-sen University