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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.
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.
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled for FAPI-PET for tumor staging or restaging
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wolfgang Fendler, MD | Contact | +49 201 723 1862 | wolfgang.fendler@uk-essen.de | |
| Lukas Kessler, MD | Contact | +49 201 723 1862 | lukas.kessler@uk-essen.de |
| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Fendler, MD | University Hospital, Essen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nuclear medicine, University hospital Essen | Recruiting | Essen | North Rhine-Westphalia | 45147 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41824221 | Derived | Kuper AT, Vaz SC, Pabst KM, Ciuciulkaite I, Mavroeidi IA, Hamacher R, Welt A, Hammersen N, Costa PF, Djaileb L, Seifert R, Umutlu L, Schuler M, Herrmann K, Fendler WP, Kummel S, Kersting D. Comparison between [68Ga]Ga-FAPI-46 and [18F]FDG PET/CT uptake in luminal-like vs. HER2-positive breast cancer. EJNMMI Res. 2026 Mar 13;16(1):58. doi: 10.1186/s13550-026-01390-3. | |
| 41506801 |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Blood samples, tissue samples
| 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 |
| Kessler L, Schwaning F, Metzenmacher M, Pabst KM, Opitz M, Wiesweg M, Aigner C, Ploenes T, Bolukbas S, Doerr F, Stuschke M, Umutlu L, Nader M, Theegarten D, Eberhardt WE, Schuler M, Herrmann K, Fendler WP, Kersting D, Hautzel H. Prognostic Value of Fibroblast Activation Protein-Directed PET Imaging in Pleural Mesothelioma. J Nucl Med. 2026 Mar 2;67(3):383-390. doi: 10.2967/jnumed.125.270906. |
| 39443386 | Derived | Watanabe M, Fendler WP, Grafe H, Hirmas N, Hamacher R, Lanzafame H, Pabst KM, Hautzel H, Aigner C, Kasper S, von Tresckow B, Stuschke M, Kummel S, Lugnier C, Hadaschik B, Grunwald V, Zarrad F, Kersting D, Siveke JT, Herrmann K, Weber M. Head-to-head comparison of 68 Ga-FAPI-46 PET/CT, 18F-FDG PET/CT, and contrast-enhanced CT for the detection of various tumors. Ann Nucl Med. 2025 Mar;39(3):255-265. doi: 10.1007/s12149-024-01993-7. Epub 2024 Oct 23. |
| 38960716 | Derived | Kessler L, Schwaning F, Metzenmacher M, Pabst K, Siveke J, Trajkovic-Arsic M, Schaarschmidt B, Wiesweg M, Aigner C, Plones T, Darwiche K, Bolukbas S, Stuschke M, Umutlu L, Nader M, Theegarten D, Hamacher R, Eberhardt WEE, Schuler M, Herrmann K, Fendler WP, Hautzel H. Fibroblast Activation Protein-Directed Imaging Outperforms 18F-FDG PET/CT in Malignant Mesothelioma: A Prospective, Single-Center, Observational Trial. J Nucl Med. 2024 Aug 1;65(8):1188-1193. doi: 10.2967/jnumed.124.267473. |
| 38960714 | Derived | Oster C, Kessler L, Blau T, Keyvani K, Pabst KM, Fendler WP, Fragoso Costa P, Lazaridis L, Schmidt T, Feldheim J, Pierscianek D, Schildhaus HU, Sure U, Ahmadipour Y, Kleinschnitz C, Guberina N, Stuschke M, Deuschl C, Scheffler B, Herrmann K, Kebir S, Glas M. The Role of Fibroblast Activation Protein in Glioblastoma and Gliosarcoma: A Comparison of Tissue, 68Ga-FAPI-46 PET Data, and Survival Data. J Nucl Med. 2024 Aug 1;65(8):1217-1223. doi: 10.2967/jnumed.123.267151. |
| 38782454 | Derived | Watanabe M, Fendler WP, Grafe H, Hirmas N, Hamacher R, Lanzafame H, Pabst KM, Hautzel H, Aigner C, Kasper S, von Tresckow B, Stuschke M, Kummel S, Lugnier C, Hadaschik B, Grunwald V, Zarrad F, Siveke JT, Herrmann K, Weber M. Prognostic Implications of 68Ga-FAPI-46 PET/CT-Derived Parameters on Overall Survival in Various Types of Solid Tumors. J Nucl Med. 2024 Jul 1;65(7):1027-1034. doi: 10.2967/jnumed.123.266981. |