This study is to explore the safety and tolerability as well as diagnostic accuracy of 68Ga-FAPI-46 for different FAP-expressing tumor entities by PET. This study does not offer any treatment for patients with FAP-expressing carcinomas; therefore, patients will be offered state of the art therapeutic options. Routine surgery will be performed within 8 weeks after 68Ga-FAPI-46 PET.
Primary Endpoint: Positive predictive value (PPV) on a per-region- and per-patient-basis of 68Ga-FAPI-46 PET for detection of histopathology-FAPpositive tumor lesions, confirmed by histopathology/biopsy (reached for ≥ 75%). Secondary Endpoints: 1. Association between 68Ga-FAPI-46 PET uptake intensity and histopathologic FAP expression 2. Sensitivity and specificity of 68Ga-FAPI-46 PET on a per-patient and per-region-basis for detection of histopathology-FAPpositive tumor lesions confirmed by histopathology/biopsy (separate for regional, extra-regional and distant locations) 3. Detection rate of 68Ga-FAPI-46 PET versus previous standard imaging on a per-patient and per-region-basis for detection of tumor location, also stratified by tumor maker serum level 4. Sensitivity and specificity of 68Ga-FAPI-46 PET versus previous standard imaging on a per-patient and per-region-basis for detection of tumor lesions confirmed by combined histopathology/biopsy/follow-up imaging/clinical follow-up reference standard (separate for regional, extra-regional and distant locations) 5. Impact on management 6. Inter-reader reproducibility 7. Safety 8. Change in staging/prognostic groups
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
158
68Ga-FAPI-46 is a radiotracer that binds with high affinity to Fibroblast Activating Protein (FAP). FAP is physiologically expressed in many tissues during embryonic development, but in adults it is expressed only in the context of wound healing, fibrotic processes, and the stroma of many malignancies. Therefore, the study seeks to validate if 68Ga-FAPI-46 PET could be established as a diagnositc tool to detect solid tumors.
Department of Nuclear medicine, University hospital Essen
Essen, North Rhine-Westphalia, Germany
Positive predictive value (PPV) on a per-region- and per-patient-basis (table 3) of 68Ga-FAPI46 PET for detection of histopathology-FAP-positive tumor lesions, confirmed by histopathology/biopsy (reached for ≥ 75%).
Time frame: within 8 weeks of FAPI-PET scan, when a tumor sample becomes available for immonostaining for FAP
Correlation between 68Ga-FAPI-46 PET uptake intensity and histopathologic FAP expression
Time frame: within 8 weeks of FAPI-PET scan, when a tumor sample becomes available for immonostaining for FAP
Sensitivity and specificity of FAPI-PET on a per-patient and per-region-basis for detection of histopathology-FAP-positive tumor lesions confirmed by histopathology/biopsy
Time frame: within 8 weeks of FAPI-PET scan, when a tumor sample becomes available for immonostaining for FAP
Detection rate of FAPI-PET versus previous standard imaging on a per-patient and per-region-basis for detection of tumor location, also stratified by tumor maker serum level
Time frame: up to time point when patient reaches end-of-study criterion (30day, if surgery is performed within 30 days after FAPI-PET or up to 8 weeks, at time of surgery/biopsy)
Sensitivity and specificity of FAPI-PET vs. previous standard imaging on a per-patient and per-region-basis for detection of tumor lesions confirmed by combined histo/biopsy/FU imaging/clinical FU reference standard
Time frame: up to time point when patient reaches end-of-study criterion (30 day, if surgery is performed within 30 days after FAPI-PET or up to 8 weeks, at time of surgery/biopsy)
Inter-reader reproducibility: determination of FAPI-PET scan interpretation reliability by three independent evaluators
Time frame: through study completion, an average of 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Safety (AEs, SAEs, SUSARs)
Time frame: From signing the ICF until day 30 after FAPI-PET scan
Change in staging/prognostic groups per survey of referring physician who was provided with FAPI-PET scan information.
Time frame: through study completion, an average of 1 year