FAPI-PET for Tumor Detection

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
68-Ga-FAPI-PET for Tumor Detection: A Prospective Observational Trial

Conditions
-----------------
Malignant Neoplasm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: FAPI-PET scheduled for staging or restaging as part of clinical routine for proven or suspected malignancy Age ≥ 18 years. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between 68Ga-FAPI PET uptake intensity and histopathologic FAP expression. Validation via immunohistochemical FAP staining/molecular analyses of pathological specimen. |  | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Rate of up- or downstaging following FAPI-PET imaging. |  | 12 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, FAP, fibroblast, FAPI, Positron-Emission-Tomography, imaging, PET