FAPI-PET for Tumor Detection

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Correlation between 68Ga-FAPI PET uptake intensity and histopathologic FAP expression. Validation via immunohistochemical FAP staining/molecular analyses of pathological specimen. [Срок оценки: 3 Months]

Вторичные конечные точки (8)

• 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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) [Срок оценки: 3 Months]
• Impact on patient management assessed by pre- and post-imaging questionnaires [Срок оценки: 12 Months]
• Detection rates on a per-patient basis of FAPI-PET stratified by tumor maker serum level and velocity [Срок оценки: 12 Months]
• Rate of up- or downstaging following FAPI-PET imaging. [Срок оценки: 12 Months]

Критерии участия

Критерии включения

• FAPI-PET scheduled for staging or restaging as part of clinical routine for proven or suspected malignancy
• Age ≥ 18 years.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 1 центр

• Department of Nuclear medicine, University hospital Essen — Essen

Публикации

• 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. PMID 41824221
• 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. PMID 41506801
• 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 PMID 39443386
• 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, O PMID 38960716
• 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. PMID 38960714
• 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/jn PMID 38782454

Идентификаторы

NCT: NCT04571086 · FAPI PET REG

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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