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

Launched by AALBORG UNIVERSITY HOSPITAL · Jan 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique called FAPI PET/CT to see how accurately it can detect pleural mesothelioma, a type of cancer that affects the lining of the lungs. The trial will involve 70 patients who have suspicious areas in their lungs and are scheduled for a biopsy. These patients will undergo FAPI PET/CT scans, which will be compared to traditional imaging methods to determine how well FAPI PET/CT can help in diagnosing this condition. For those already receiving cancer treatment, additional scans will be done to evaluate the response to treatment.

To participate in this study, patients must be at least 18 years old, have suspicious pleural lesions, and have already undergone a standard imaging test called FDG PET/CT. However, some people may not be eligible, such as those needing immediate surgery, pregnant or breastfeeding women, or those with certain medical conditions. Throughout the study, the assessments will be conducted carefully to ensure they don’t affect the patients' ongoing treatment. Participants can expect a supportive environment and detailed information about their involvement in the research.

Gender

ALL

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 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.