Clinical trial · Observational
FAPI-PET for Tumor Detection
68-Ga-FAPI-PET for Tumor Detection: A Prospective Observational Trial
NCT04571086CI-TRIAL-00071783recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Correlation between 68Ga-FAPI PET uptake intensity and histopathologic FAP expression. Validation via immunohistochemical FAP staining/molecular analyses of pathological specimen.
- timeFrame
- 3 Months
Secondary outcomes (8)
- measure
- 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.
- timeFrame
- 3 Months
- measure
- 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.
- timeFrame
- 3 Months
- measure
- 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.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (6)
- DERIVEDKuper 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
- DERIVEDKessler 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
- DERIVEDWatanabe 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. PMID 39443386
- DERIVEDKessler 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. PMID 38960716
- DERIVEDOster 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.