The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAalborg University Hospital
About this trial
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
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- [68Ga]Ga-FAPI-46 PET/CT
Treatment groups
70 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov