From the blog

The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma (FAPI-PM)

Published: January 24, 2025

Primary Outcome Measures

  • Calculate the proportion of patients where the location of the intended pleural biopsy is altered due to FAPI PET/CT replacing FDG PET/CT.

Secondary Outcome Measures

  • Compare the cancer stage (IASCL 9th edition TNM-classification) as determined by FAPI PET/CT compared to conventional imaging (including FDG PET/CT) at primary staging.
  • Calculate the proportion of patients with suspected PM lesion with a change in treatment following the -hypothetical – addition of FAPI PET/CT at primary staging.
  • Investigate the FAPI PET uptake parameters in suspicious PM lesions (primary tumor), regional lymph nodes, and distant metastases, and in benign lesions. Correlate FAPI uptake parameters in different PM subtypes.
  • Calculate changes in FAPI PET uptake parameters – from before to after 2-3 series of anticancer treatment. Changes will be presented as ratios and in %.
  • Correlate the FAPI PET SUV to FAP targeting immunohistochemistry of biological material.
  • Seek supplementary information in medical records, biochemistry, pathology, or other imaging modalities for a final diagnosis/condition in cases of unexpected FAPI PET/CT findings.
  • Report Incidence Treatment-Emergent Adverse Events
  • A 10 year follow up of included patients will be conducted to determine overall survival (OS) in days from diagnosis, correlated to FAPI PET/CT results.
  • A 10 year follow up of included patients will be conducted to determine Recurrence Free Survival (RFS) and Progression Free Survival (PFS) in days from diagnosis, correlated to FAPI PET/CT results.
  • Compare conventional CT-based response assessment (mRECIST/iRECIST) to PET based response assessment (PERCIST, and other FDG and FAPI PET derived data) to the clinical outcome, i.e., OS, RFS/PFS.
  • Conduct an interobserver study of FAPI PET/CTs. Cohens Kappa d will be calculated.

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).
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