Actively Recruiting
The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma
Led by Aalborg University Hospital · Updated on 2025-07-03
70
Participants Needed
1
Research Sites
639 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with pleural lesions suspicious of pleural mesothelioma and referred to pleural biopsy
- Have undergone or are undergoing FDG PET/CT as part of the diagnostic workup for suspected PM lesion
- Considered physically and mentally able to participate in the research project
- Understands the study information and can consent to participate
- 18 years or older
You will not qualify if you...
- Patients needing urgent surgery or emergency treatment
- Known other active cancers treated within the last year (except non-melanoma skin cancer or cervical cancer in situ)
- Pregnant or breastfeeding women
- Fertile women who may be pregnant without confirmed negative pregnancy test
- Unable to undergo PET/CT due to weight over 180 kg, inability to fit or remain still in scanner, severe claustrophobia or needle fear
- Medical conditions or circumstances that may affect study reliability or completion
- History of allergic reactions to FDG or FAPI tracers
AI-Screening
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Trial Site Locations
Total: 1 location
1
Aalborg University Hospital
Aalborg, Region North Jutland, Denmark, 9000
Actively Recruiting
Research Team
M
Morten Bentestuen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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