Evaluating FAPI PET for diagnosing 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
This study is testing a new type of imaging called FAPI PET/CT to see if it can better diagnose pleural mesothelioma in patients compared to standard imaging methods.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aalborg University Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Aalborg, Region North Jutland) |
| Trial ID | NCT06790082 on ClinicalTrials.gov |
What this trial studies
This study involves 70 patients with suspected pleural mesothelioma who will undergo FAPI PET/CT imaging in addition to conventional FDG PET/CT imaging. The aim is to assess the diagnostic accuracy of FAPI PET/CT compared to histopathology, which will serve as the reference standard. Additionally, patients receiving anticancer treatments will have follow-up FAPI and FDG PET/CT scans to evaluate treatment response. The study is designed to be blinded to ensure that the imaging results do not influence patient management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with pleural lesions suspicious for mesothelioma who are referred for biopsy.
Not a fit: Patients with an imminent need for surgery or those with other active malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing pleural mesothelioma and potentially lead to better treatment decisions.
How similar studies have performed: Previous studies have shown promising results for FAPI PET in other cancer types, indicating potential success for this approach in pleural mesothelioma.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aalborg, Region North Jutland
- Aalborg University Hospital — Aalborg, Region North Jutland, Denmark (Recruiting)
Study contacts
- Study coordinator: Morten Bentestuen, MD
- Email: m.bentestuen@rn.dk
- Phone: +45 97665500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.