NCT04272658招募中不适用
Interest in PET/CT Whole-body Dynamic Acquisition at FDG to Differentiate Progression/Pseudo Progression of Metastatic Melanoma Under Immunotherapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Values of the Ki absorption coefficient resulting from a FDG PET / CT full-body 4D dynamic acquisition to differentiate the pseudo-progression / progression of metastatic melanoma treated with ICI
研究概览
简要总结
The value of 4D body-to-whole dynamic acquisition in FDG PET / CT to differentiate progression / pseudo-progression during the first therapeutic assessment (PET1) of metastatic melanoma treated with immune checkpoint inhibitors (ICI)to predict the progression of the disease..
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
- •Patient old ≥ 18 years
- •With metastatic melanoma
- •Treated with anti-PD1 : Nivolumab or Pembrolizumab or Combo IPI-Nivo
- •Having formulated a non-opposition
排除标准
- •- Minor patient < 18 years
- •Pregnancy or breastfeeding
- •Other type of tumor than metastatic melanoma
- •Non-eligibility for the examination
- •Refusal of participation
结局指标
主要结局
Values of the Ki absorption coefficient resulting from a FDG PET / CT full-body 4D dynamic acquisition to differentiate the pseudo-progression / progression of metastatic melanoma treated with ICI
时间窗: 5 years
次要结局
- Correlation between the Ki lesional values resulting from the 4D acquisition of the PET / CT from PET1 and PET0 the biological parameters (LDH, leucocytes, neutrophils) to differentiate pseudo-progression / progression(5 years)
- Correlation between the Ki lesion values derived from PET1 and the quantitative parameters resulting from PET0 histological specifications of the tumors (% PD-L1, T-CD8 infiltration, PTEN status) to differentiate pseudo-progression / progression.(5 years)
- Correlation between the Ki lesion values resulting from the 4D acquisition of FDG PET / CT for PET1 and the quantitative parameters resulting from PET0 to differentiate pseudo-progression / progression(5 years)
- Correlation between lesional Ki values resulting from the 4D acquisition of FDG PET / CT for from PET1 and the quantitative parameters resulting from PET0 ICI- related adverse effect to differentiate pseudo-progression / progression(5 years)
研究者
研究点 (1)
Loading locations...
相似试验
暂停
不适用
Dynamic whole body data acquisition in PET/CT diagnostics: a prospective data collection in clinically indicated examinationsOncological diseases.Inflammatory forms of disease (e.g. fever of unclear origin, vasculitis, spondylodiscitis or unclear inflammation in the chest / pulmonary etc.)C15.9C43C83C14C32C80C19C53C54C85I77Oesophagus, unspecifiedMalignant melanoma of skinNon-follicular lymphomaMalignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynxMalignant neoplasm of larynxMalignant neoplasm, without specification of siteMalignant neoplasm of rectosigmoid junctionMalignant neoplasm of cervix uteriMalignant neoplasm of corpus uteriOther and unspecified types of non-Hodgkin lymphomaOther disorders of arteries and arteriolesDRKS00021217niversitätsklinikum Tübingen, Radiologische Klinik, Nuklearmedizin & Klinische Molekulare Bildgebung300
已完成
不适用
Dynamic study of FDG-PET/CTJPRN-UMIN000023983Tokushima University Hospital50
已完成
不适用
Dynamic whole-body [18F]FDG-PET/CT for patients with lung cancerC34Malignant neoplasm of bronchus and lungDRKS00017717niversitätsklinikum Tübingen, Nuklearmedizin38
Unknown
不适用
Total-body PET / CT in the Evaluation of Treatment and Prognosis of LymphomaLymphomaNCT04931875RenJi Hospital100
已完成
不适用
Dynamic FDG PET/CT: Optimization and Validation of Data AcquisitionPositron-Emission TomographyNCT04660279Aarhus University Hospital20