PET/CT and Sentinel Node in Oral Cancer (PETNode)
Dual-time PET/CT and Sentinel Node Diagnostics Preoperatively in Patients With Oral Cancer
In this study, the investigators want to pre-operatively scan patients who do not have any clinically suspicion of metastases with an 18F-FDG-PET/CT whole body scan , where after they go to lymphoscintigraphy incl. SPECT/CT and sentinel node biopsy. Material from the oral cancer and, after permission of each patient, also normal oral tissue will be analyzed molecular-biologically. Also a blood sample will be analyzed for molecular tumor markers.
The investigators want to see if PET/CT is able to detect any signs of sub-clinically metastases. Besides, the investigators want to fusion PET/CT with SPECT/CT data from the lymphoscintigraphy study and improve our PET/CT scanning with a dual-time PET scan of the head-and-neck region.
研究概览
地位
条件
详细说明
These patients are normally preoperatively sent to a CT scan of the thorax and abdomen; in this study, this CT is replaced by a wholebody PET/CT scan. Afterwards, the patients goes to sentinel node lymphoscintigraphy and then to operation.
By combining biomarkers and molecular imaging in patients with a clinically T1/T2N0M0 oral cancer, we want to characterize the tumor physiologically and correlate these physiological features to the clinical appearance of the cancer.
Aims of the study:
- can PET/CT in this patient group metastases with consequently change of treatment?
- can fusion of SPECT/CT and PET/CT with calculation of standardized uptake value (SUV) indicate, how much tumor tissue there should be in a positive sentinel node to be detected by PET?
- can dual-time PET scanning better determine lymph node metastases, than single-time PET scanning?
- correlation between SUV in PET with molecular-biological findings both in the primary tumor and in metastases
研究类型
注册 (预期的)
联系人和位置
学习地点
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Copenhagen、丹麦、2100
- Dep. of Nuclear Medicine & PET
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Copenhagen、丹麦、2100
- Dep. of otorhinolaryngology, Head & Neck Surgery/ Rigshospitalet
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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:
- biopsy-verified oral cancer
- over 18 years of age
Exclusion Criteria:
- under 18 years of age
- inable patients
- pregnancy
- known allergy to contrast agents
- kidney insufficiency
- other known cancer
- diabetes mellitus
- acute medical conditions such as acute infection, acute cardial or lung disease or other intercurrent diseases
学习计划
研究是如何设计的?
设计细节
合作者和调查者
调查人员
- 首席研究员:Christine W Dümcke, Dr.、Dep. of Nuclear Medicine & PET
研究记录日期
研究主要日期
学习开始
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 (估计)
研究记录更新
最后更新发布 (估计)
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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