68-Ga-FAPI-PET for Tumor Detection: A Prospective Observational Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Correlation between 68Ga-FAPI PET uptake intensity and histopathologic FAP expression. Validation via immunohistochemical FAP staining/molecular analyses of pathological specimen.
研究概览
简要总结
This is a prospective observational trial investigating correlation with histopathology, positive predictive value, detection rate, reproducibility and impact on clinical management of 68-Ga-FAPI PET/CT or PET/MRI in patients receiving this imaging modality for tumor staging or restaging as part of clinical care.
详细描述
68-Ga-fibroblast-activation-protein-inhibitors (68-Ga-FAPI) are novel Positron emission tomography (PET) tracers that were recently introduced for the imaging of patients with various cancer diseases. The fibroblast-activation-protein (FAP) is highly expressed in carcinoma-associated fibroblasts (CAFs) in the stroma of various tumor entities. The aim of this registry study is to collect data on FAPI expression, positive predictive value, detection rate, reproducibility and impact on clinical management of 68-Ga-FAPI PET/CT or PET/MRI on patients receiving this imaging modality at initial diagnosis or restaging as part of clinical care.
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
- •FAPI-PET scheduled for staging or restaging as part of clinical routine for proven or suspected malignancy
- •Age ≥ 18 years.
排除标准
- •Patient cannot give consent for the study
- •Patient can not lie flat or tolerate FAPI PET imaging
- •Unwillingness or inability to comply with study and follow-up procedures
- •Condition of patient which is critical to participate in this study in the discretion of the investigators
- •Pregnant, lactating, or breast feeding women.
结局指标
主要结局
Correlation between 68Ga-FAPI PET uptake intensity and histopathologic FAP expression. Validation via immunohistochemical FAP staining/molecular analyses of pathological specimen.
时间窗: 3 Months
次要结局
- Detection rate on a per-patient-basis of FAPI-PET for detection of tumor location, confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.(3 Months)
- Positive predictive value (PPV) on a per-region-basis of FAPI-PET for detection of tumor location, confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.(3 Months)
- Impact on patient management assessed by pre- and post-imaging questionnaires(12 Months)
- Detection rates on a per-patient basis of FAPI-PET stratified by tumor maker serum level and velocity(12 Months)
- Detection rate on a per-region-basis of FAPI-PET for detection of tumor location, confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.(3 Months)
- Positive predictive value (PPV) on a per-patient-basis of FAPI-PET for detection of tumor location, confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.(3 Months)
- Rate of up- or downstaging following FAPI-PET imaging.(12 Months)
- Sensitivity and specificity of FAPI PET on a per-patient and per-region-basis for detection of tumor location confirmed by histopathology/biopsy (separate for regional, extra-regional and distant locations)(3 Months)
研究者
PD Dr. med. Wolfgang Fendler
MD
University Hospital, Essen