RecruitingPhase 2NCT06790082

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


Sponsor

Aalborg University Hospital

Enrollment

70 participants

Start Date

Jan 29, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new type of PET scan (a detailed imaging test) called FAPI PET to see how accurately it can detect and stage pleural mesothelioma — a rare cancer of the lining around the lungs often associated with asbestos exposure. The study compares FAPI PET to the current standard scan (FDG PET/CT) to see if it provides better information for diagnosis and treatment planning. **You may be eligible if...** - You are 18 years or older - You have suspicious lesions in the lining of the lung (pleura) being investigated for possible mesothelioma - You have been referred for a pleural biopsy (tissue sample) - You have already had or are scheduled to have a standard FDG PET/CT scan as part of your workup - You are physically and mentally capable of participating **You may NOT be eligible if...** - You need urgent surgery - You have another active cancer being treated within the past year - You are pregnant, breastfeeding, or could potentially be pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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NCT06790082


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