1. Correlation between 68Ga-FAPI PET uptake intensity and histopathologic FAP expression. Validation via immunohistochemical FAP staining/molecular analyses of pathological specimen. (Time Frame - 3 Months)
Secondary outcome:
1. 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. (Time Frame - 3 Months)
2. 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. (Time Frame - 3 Months)
3. 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. (Time Frame - 3 Months)
4. 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. (Time Frame - 3 Months)
5. 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) (Time Frame - 3 Months)
6. Impact on patient management assessed by pre- and post-imaging questionnaires (Time Frame - 12 Months)
7. Detection rates on a per-patient basis of FAPI-PET stratified by tumor maker serum level and velocity (Time Frame - 12 Months)
8. Rate of up- or downstaging following FAPI-PET imaging. (Time Frame - 12 Months)
Quelle: ClinicalTrials.gov
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