Clinical Trial

The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma

Study acronym: FAPI-PM
Recruiting Phase 2
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-22.
Trial Details
NCT Number NCT06790082
Lead Sponsor Aalborg University Hospital
Conditions Pleural Mesothelioma, Pleural Diseases, Cancer, FAPI, Fibroblast Activation Protein Inhibitor
Enrollment 70 participants
Start Date 2025-01-29
Primary Completion 2027-04-30 (estimated)
Study Completion 2037-04-30 (estimated)
Updated on ClinicalTrials.gov 2025-07-03