The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAalborg University Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Pregnant or breastfeeding women.
Fertile women (women of childbearing potential) who could - theoretically - be pregnant (i.e., unknown pregnancy status).
Trial design
Design model
Single group
Treatments tested in this trial
[68Ga]Ga-FAPI-46 PET/CT
DrugPatients 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.
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: Suspected pleural mesotheliomaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic Performance
The diagnostic performance (sensitivity, specificity, positive predicative value, negative predicative value, and overall diagnostic accuracy - all parameters in %). in of FAPI PET compared to routine imaging modalities, including FDG PET/CT, in suspected PM lesions.
Time frame
2 yearsSecondary outcomes
1
Location biopsy
Calculate the proportion of patients where the location of the intended pleural biopsy is altered due to FAPI PET/CT replacing FDG PET/CT.
Time frame
2 years2
Staging
Compare the cancer stage (IASCL 9th edition TNM-classification) as determined by FAPI PET/CT compared to conventional imaging (including FDG PET/CT) at primary staging.
Time frame
2 years3
Patient Management
Calculate the proportion of patients with suspected PM lesion with a change in treatment following the -hypothetical - addition of FAPI PET/CT at primary staging.
Time frame
2 years4
Uptake Values
Investigate the FAPI PET uptake parameters in suspicious PM lesions (primary tumor), regional lymph nodes, and distant metastases, and in benign lesions. Correlate FAPI uptake parameters in different PM sutypes.
Time frame
2.5 yearsSponsors and contacts
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Source ClinicalTrials.gov