RecruitingPhase 2NCT06790082

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

Sponsor

Aalborg University Hospital

Enrollment

70 participants

Start Date

Jan 29, 2025

Study Type

INTERVENTIONAL

Conditions

Cancer Pleural Mesothelioma Pleural Diseases FAPI Fibroblast Activation Protein Inhibitor

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

Min Age: 18 Years

Inclusion Criteria5

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.
years or older

Exclusion Criteria8

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.

Interventions

DRUG[68Ga]Ga-FAPI-46 PET/CT

Patients with suspected pleural mesothelioma undergo FAPI PET/CT in addition to conventional imaging at primary staging. The subgroup of patients undergoing anticancer treatment will undergo an additional FAPI PET/CT and FDG PET/CT after completing 2-3 series of anticancer treatment.