NCT06790082RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 10 Jan 2025
- Start date
- 29 Jan 2025
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Aalborg University Hospital
- Diseases
- Mesothelioma, Lung cancer
- NCT number
- NCT06790082
- EU CT number
- 2024-514301-62-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 70
- From 29 Jan 2025 to the primary completion date, 30 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- 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).
Other
- Pregnant or breastfeeding women.
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.