Evaluating FAPI PET for diagnosing pleural mesothelioma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Aalborg University Hospital
  Aalborg, Region North Jutland, Denmark Recruiting

Study contacts

• Study coordinator: Morten Bentestuen, MD
• Email: m.bentestuen@rn.dk
• Phone: +45 97665500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.