Malignant Neoplasm
Conditions
Keywords
FAPI, cancer, Positron-Emission-Tomography, FAP, fibroblast, imaging, PET
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.
Interventions
None listed
Sponsors
University Hospital, Essen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
1. FAPI-PET scheduled for staging or restaging as part of clinical routine for proven or suspected malignancy 2. Age ≥ 18 years.
Exclusion criteria
1. Patient cannot give consent for the study 2. Patient can not lie flat or tolerate FAPI PET imaging 3. Unwillingness or inability to comply with study and follow-up procedures 4. Condition of patient which is critical to participate in this study in the discretion of the investigators 5. Pregnant, lactating, or breast feeding women.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Germany
Contacts
Primary ContactWolfgang Fendler, MD
Backup ContactLukas Kessler, MD
Outcome results
None listed