NCT06790082 The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma
| NCT ID | NCT06790082 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Aalborg University Hospital |
| Condition | Pleural Mesothelioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-01-29 |
| Primary Completion | 2027-04-30 |
Trial Parameters
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Brief 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.
Eligibility Criteria
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 t