Post-treatment Ultrasensitive Positron Emission Tomography in Nasopharyngeal Carcinoma Patients
研究概览
详细说明
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.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Guangdong
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Guangzhou、Guangdong、中国、510060
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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 0-1.
- 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)
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
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PET CT and ultrasensitive PET CT
Patients receiving chemoradiotherapy will receive a dedicated FDG PET/CT and ultrasensitive PET CT protocol 12 weeks after the end of IMRT .
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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.
Its total-body coverage and exceptional sensitivity provide opportunities for innovative studies of physiology, biochemistry, and pharmacology.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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results of ultrasensitive and normal PET CT
大体时间:6 months
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The results of the two tests were compared to verify the specificity and sensitivity of ultrasensitive PET CT in post treatment NPC
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6 months
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合作者和调查者
调查人员
- 首席研究员:Haiqiang Mai, Dr、Sun Yat-sen University
出版物和有用的链接
一般刊物
- Zhang X, Cherry SR, Xie Z, Shi H, Badawi RD, Qi J. Subsecond total-body imaging using ultrasensitive positron emission tomography. Proc Natl Acad Sci U S A. 2020 Feb 4;117(5):2265-2267. doi: 10.1073/pnas.1917379117. Epub 2020 Jan 21.
- Zhang X, Xie Z, Berg E, Judenhofer MS, Liu W, Xu T, Ding Y, Lv Y, Dong Y, Deng Z, Tang S, Shi H, Hu P, Chen S, Bao J, Li H, Zhou J, Wang G, Cherry SR, Badawi RD, Qi J. Total-Body Dynamic Reconstruction and Parametric Imaging on the uEXPLORER. J Nucl Med. 2020 Feb;61(2):285-291. doi: 10.2967/jnumed.119.230565. Epub 2019 Jul 13.
- Lv Y, Lv X, Liu W, Judenhofer MS, Zwingenberger A, Wisner E, Berg E, McKenney S, Leung E, Spencer BA, Cherry SR, Badawi RD. Mini EXPLORER II: a prototype high-sensitivity PET/CT scanner for companion animal whole body and human brain scanning. Phys Med Biol. 2019 Mar 21;64(7):075004. doi: 10.1088/1361-6560/aafc6c.
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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