Post-treatment Ultrasensitive Positron Emission Tomography in Nasopharyngeal Carcinoma Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- results of ultrasensitive and normal PET CT
研究概览
简要总结
NPC Patients receiving IMRT treatment will receive a dedicated FDG PET/CT and high-sensitivity PET/CT protocol simultaneously in the follow-up of Locally Advanced Nasopharyngeal Carcinoma. Hence we establish this prospective cohort study.
详细描述
Newly-diagnosed patients with stage III or IV non-metastatic Nasopharyngeal Carcinoma (AJCC 8th) will be recruited. All subjects receiving chemoradiotherapy will undergo a baseline integrated [18F]fluoro-2-deoxy-D-glucose (FDG) positron emission tomography/computed tomography (PET/CT) scan or traditional follow-up examination before the start of chemoradiotherapy.
NPC Patients receiving IMRT treatment will receive a dedicated FDG PET/CT and high-sensitivity PET/CT protocol simultaneously 12 weeks after the end of chemoradiotherapy (primary endpoint).
The results of FDG PET/CT and high-sensitivity PET/CT analyzed and compared.
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 70 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 18-70, male/female.
- •Staged III or IV (AJCC 8th) NPC patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, WHO II and III).
- •Received induction chemotherapy and/or concurrent chemoradiotherapy. ECOG scale 0-
- •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
- •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
results of ultrasensitive and normal PET CT
时间窗: 6 months
The results of the two tests were compared to verify the specificity and sensitivity of ultrasensitive PET CT in post treatment NPC
次要结局
未报告次要终点
研究者
Hai-Qiang Mai,MD,PhD
Chief Physician
Sun Yat-sen University