Clinical trial · Interventional
The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma
FAPI PET in Pleural Mesothelioma: The Diagnostic Accuracy and Clinical Value of FAPI PET at Diagnosis, Primary Staging, and the Feasibility of FAPI PET for Response Evaluation
- 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)
Seventy (N=70) patients with suspected pleural mesothelioma (PM) lesions referred to pleural biopsy will be recruited, and undergo an additional FAPI PET/CT at primary staging. The FAPI PET/CT results will be compared to conventional imaging (including FDG PET/CT). The diagnostic accuracy will be determined with histopathology as reference standard. For patients undergoing anticancer treatment (chemotherapy, immunotherapy, other treatment), an additional FAPI PET/CT and an additional FDG PET/CT will be conducted after the study subjects have completed 2-3 series of anticancer treatment. The feasabilitiy of FAPI PET/CT in response evaluation will be investigated. All study specific analyzes will be blinded and will not influence the patient management / treatment.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| FAPI | — | UNRESOLVED | — |
| Fibroblast Activation Protein Inhibitor | — | UNRESOLVED | — |
| Pleural Diseases | — | UNRESOLVED | — |
| Pleural Mesothelioma | Pleural Mesothelial Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]Ga-FAPI-46 PET/CT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Suspected pleural mesothelioma
- description
- Patients with suspected pleural mesotheliom undergo an additional study specific \[68Ga\]Ga-FAPI-46 PET/CT at primary staging.
- interventionNames
- Drug: [68Ga]Ga-FAPI-46 PET/CT
Primary outcomes (1)
- measure
- Diagnostic Performance
- timeFrame
- 2 years
- description
- The diagnostic performance (sensitivity, specificity, positive predicative value, negative predicative value, and overall diagnostic accuracy - all parameters in %). in of FAPI PET compared to routine imaging modalities, including FDG PET/CT, in suspected PM lesions.
Secondary outcomes (12)
- measure
- Location biopsy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with pleural lesions suspicious of pleural mesothelioma and referred to pleural biopsy. * Undergone/undergoing FDG PET/CT as part of the diagnostic workup of a suspicious PM lesion. * Considered physically and mentally able to participate in the research project. * Understands the study subject information and able to consent to project participation. * 18-years or older Exclusion Criteria: * Patients with an imminent need for surgery or in an emergency * Known concurrent other malignancy with active treatment within the last 1 year; non-melanoma skin cancer and cervical cancer in situ are exempt. * Pregnant or breastfeeding women. * Fertile women (women of childbearing potential) who could - theoretically - be pregnant (i.e., unknown pregnancy status). Fertile women will be tested for pregnancy (by urine humane choriogonadotropin (HCG) or serum HCG) within 48h before FAPI PET/CTs, both at primary staging and restaging. Study subjects can participate in the study if the pregnancy test is negative (i.e., not pregnant). * Subjects unable to undergo PET/CT: e.g., weighing more than 180 kg (weight limit scanner), unable to fit within the imaging gantry, inability to remain still for the duration of the examination, or with known severe claustrophobia unresponsive to oral anxiolytics or severe fear of needles. * Subjects with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease the reliability of data, achievement of study objectives or completing the study. * History of allergic reactions / hypersensitivity attributed to \[18F\]FDG or FAPI-tracers.
References
Publications (3)
- BACKGROUNDGuglielmo P, Crivellaro C, Castello A, Della Corte CM, Pagano M, Marchesi S, Occhipinti M, Zucali PA, Evangelista L. Emerging Radiopharmaceuticals in Pet Imaging for Mesothelioma: A Review of [18F]FDG Alternatives. Mol Diagn Ther. 2025 Jan;29(1):55-66. doi: 10.1007/s40291-024-00756-4. Epub 2024 Nov 8. PMID 39514167
- BACKGROUNDGuzel Y, Komek H, Can C, Kaplan I, Kepenek F, Ebinc S, Buyukdeniz MP, Gundogan C, Oruc Z. Comparison of the role of 18 F-fluorodeoxyglucose PET/computed tomography and 68 Ga-labeled FAP inhibitor-04 PET/CT in patients with malignant mesothelioma. Nucl Med Commun. 2023 Jul 1;44(7):631-639. doi: 10.1097/MNM.0000000000001702. Epub 2023 Apr 28. PMID 37114422
- BACKGROUNDKessler 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