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RECRUITING
NCT06790082
PHASE2

The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma

Sponsor: Aalborg University Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2025-01-29

Completion Date

2037-04-30

Last Updated

2025-07-03

Healthy Volunteers

No

Interventions

DRUG

[68Ga]Ga-FAPI-46 PET/CT

Patients with suspected pleural mesothelioma undergo FAPI PET/CT in addition to conventional imaging at primary staging. The subgroup of patients undergoing anticancer treatment will undergo an additional FAPI PET/CT and FDG PET/CT after completing 2-3 series of anticancer treatment.

Locations (1)

Aalborg University Hospital

Aalborg, Region North Jutland, Denmark