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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Aalborg University Hospital
RECRUITING
Aalborg
Contact Information
Primary
Morten Bentestuen, MD
m.bentestuen@rn.dk
+45 97665500
Time Frame
Start Date: 2025-01-29
Estimated Completion Date: 2037-04-30
Participants
Target number of participants: 70
Treatments
Experimental: Suspected pleural mesothelioma
Patients with suspected pleural mesotheliom undergo an additional study specific \[68Ga\]Ga-FAPI-46 PET/CT at primary staging.
Related Therapeutic Areas
Sponsors
Leads: Aalborg University Hospital

This content was sourced from clinicaltrials.gov

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