Diagnostic Performance Of 4D Dynamic LAFOV FDG-PET Acquisition for Differentiation of Residual Disease and Post-radiation Inflammation in Head Neck SCC Treated by Radiotherapy.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- Parameters obtained using the Patlak Direct IDIF reconstruction method, Ki mean, Ki max, DV mean and DV max (standards) in FDG-PET LAFOV in the residual disease and post-treatment inflammation groups
研究概览
简要总结
This multicenter prospective observational study will evaluate the value of dynamic FDG-PET LAFOV imaging during the initial therapeutic assessment of a head and neck cancer 3 months after completion of curative radiotherapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient ≥ 18 years of age
- •Presenting with head and neck squamous cell carcinoma
- •Completed curative treatment with external radiation therapy
- •Eligible for dynamic LAFOV FDG-PET scan for therapeutic evaluation at 3 months
- •Having given consent for the end-of-treatment consultation
排除标准
- •Hypersensitivity to 18F-FDG or other excipients contained in the contrast agent
- •Pregnancy or breastfeeding
- •History of treated upper gastrointestinal tract cancer
- •Other histology
- •Incomplete RTE treatment regimen
- •Refusal to participate
结局指标
主要结局
Parameters obtained using the Patlak Direct IDIF reconstruction method, Ki mean, Ki max, DV mean and DV max (standards) in FDG-PET LAFOV in the residual disease and post-treatment inflammation groups
时间窗: 3 months post-curative radiotherapy
The reference test for the diagnosis of " residual diseases " and " post-radiation inflammation" will be based on the conclusion of the multidisciplinary team meeting ruling on the results of composite data, including clinical examination, pathological examination, morphological imaging (CT or MRI) and/or functional imaging (early evaluation PET). The index test will be based on FDG-PET LAFOV whose parameters obtained using the Patlak Direct IDIF, Ki mean, Ki max, DV mean and DV max (standards) in the residual disease and post-therapy inflammation groups.
次要结局
- Standard Ki and DV parameters in LAFOV FDG-PET and anatomical pathology characteristics of tumours (p16 status, CPS, degree of tumour differentiation).(3 months post-curative radiotherapy)
- Dynamic (standard Ki and DV) and static (SUVmax, SUVmean, SUVpeak, MTV, TLG, textural features) parameters in LAFOV FDG-PET.(3 months post-curative radiotherapy)
- Ki and DV parameters in LAFOV FDG-PET and the occurrence of post-radiation toxicity(3 months post-curative radiotherapy)
- Dates of imaging, dates of progression, dates of death and end of study dates(12 months post TEP-FDG LAVOF imaging)
- DV and Ki parameters derived from direct and indirect Patlak reconstructions with IDIF and/or PBIF.(3 months post-curative radiotherapy)