(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-CYANO-4,4-DIFLUOROPYRROLIDIN-1-YL)-2-OXOETHYLCARBAMOYL)-QUINOLIN-6-YL)(METHYL)AMINO)-PROPYL)PIPERAZIN-1-YL)-2-OXOETHYL)-68GA-[1,4,7,10]-TETRAAZACYCLODODECANE-1,4,7-TRIYL)TRIACETATE for Pleural mesothelioma

Inclusion criteria

• {"criterion_text":"- Patients with pleural lesions suspicious of pleural mesothelioma and referred to biopsy.\n- Undergone/undergoing FDG PET/CT as part of the diagnostic workup of a suspicious PM lesion\n- Considered physically and mentally able to participate in the research project\n- Understands the study subject information and able to consent to project participation\n- 18-years or older"}

Exclusion criteria

• {"criterion_text":"- Patients with an imminent need for surgery or in an emergency\n- Known concurrent other malignancy with active treatment within the last 1 year; non-melanoma skin cancer and cervical cancer in situ are exempt\n- Pregnant or breastfeeding women\n- Fertile women not using effective contraceptives\n- Subjects unable to undergo PET/CT\n- History of allergic reactions / hypersensitivity attributed to [ 18F]FDG or FAPI-tracers\n- Subjects with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease the reliability of data, achievement of study objectives or completing the study"}

Primary endpoints

• {"endpoint_text":"- Compare the FAPI PET/CT and FDG PET/CT findings in primary tumor, regional lymph nodes and distant metastases to a histopathological reference standard where the sensitivity, specificity, PPV, and NPV of the PET/CTs are determined at primary staging","definition_or_measurement_approach":"Comparison of FAPI PET/CT and FDG PET/CT findings to a histopathological reference standard at primary staging with determination of sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)."}

Secondary endpoints

• {"endpoint_text":"- Calculate the proportion of patients where the location of the intended pleural biopsy is altered due to FAPI PET/CT replacing FDG PET/CT and other imaging modalities’ role in guiding the pleural biopsy. This will be determined at the tentative MDT.\n- Compare the cancer stage (IASCL 8 th edition TNM-classification) as determined by FAPI PET/CT compared to conventional imaging (including FDG PET/CT) at primary staging. The proportion of patients downstaged, unchanged stage, and upstaged, due to the added FAPI PET/CT are determined.\n- 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. The proportion of patients hypothetically treated differently, as deemed by collaborating clinicians participating in the tentative MDT, due to more advanced disease or less advanced disease, are determined.\n- Measure/calculate standardized uptake value (SUV) and tumor to background ratio (TBR) values for pleural PM lesions, regional lymph nodes, and distant metastases for FAPI PET/CT and compare these values to FDG PET, both at primary staging and after 2-3 series of anticancer treatment.\n- Measure/calculate FAPI PET SUV and TBR in benign pleural lesions, as revealed upon histopathology or composite reference standard, and compare these values to those derived from the primary FDG PET.\n- Calculate changes in SUV and TBR in primary, regional lymph nodes, and distant metastases for FAPI PET - from before to after 2-3 series of anticancer treatment and compare these values to the changes in the FDG PET parameters\n- Measure/calculate MITV (Molecular Imaging Tumor Volume) and VIP (Volume Intensity Product) for both FAPI PET/CT and FDG PET/CT at primary staging and after 2-3 series of anticancer treatment and compare these values between FAPI PET/CT and FDG PET/CT.\n- Calculate changes in MITV and VIP for both FAPI PET/CT and FDG PET/CT from before to after neoadjuvant chemotherapy and compare these values between FAPI PET/CT and FDG PET/CT.\n- Correlate the FAPI PET and FDG PET uptake parameters (SUV, TBR, MITV, VIP) to the subtype of PM (epithelioid, biphasic, sarcomatoid).\n- A 10 year follow up of included patients will be conducted to determine overall survival (OS), Recurrence Free Survival (RFS) and Progression Free Survival (PFS). These will be compared between FAPI PET/CT based markers (e.g., tentative FAPI PET stage, SUV, TBR, MITV, VIP) and other common clinical practice derived markers (e.g., FDG PET staging, other biomarkers).\n- Compare conventional CT-based response assessment (mRECIST/iRECIST) to PET based response assessment (PERCIST, and other FDG and FAPI PET derived data) to the clinical outcome, i.e., OS, RFS/PFS.\n- Conduct an interobserver study of FAPI PET/CTs performed in the present and other future FAPI PET/CT cancer studies conducted at Aalborg UH.\n- Seek supplementary information in medical records, biochemistry, pathology, or other imaging modalities for a final diagnosis/condition in cases of unexpected FAPI PET/CT findings.\n- Correlate the FAPI PET SUV to FAP targeting immunohistochemistry. Furthermore, FAP based volumedensity estimations pleural biopsies will be conducted and sought correlated with the FAPI PET SUV.\n- Report potential AEs and ARS related to the [68Ga]Ga-FAPI-46 injection.","definition_or_measurement_approach":"Secondary endpoints include proportions (e.g., proportion of patients with changed biopsy location or change in treatment), comparative staging (IASLC 8th TNM comparison), quantitative PET metrics (SUV, TBR, MITV, VIP) measured on FAPI PET/CT and FDG PET/CT at baseline and after 2-3 treatment series, correlations with histopathology and immunohistochemistry, interobserver agreement studies, and long-term clinical outcomes (10-year follow-up for OS, RFS, PFS). Statistical analyses include calculation of proportions, comparisons between imaging modalities, correlation analyses and survival analyses as applicable."}

Denmark

Earliest CTIS Part Ii Submission Date

18-09-2024

Latest Decision Or Authorization Date

17-04-2026

Processing Time Days

576

Number Of Sites

1

Number Of Participants

70

Primary sponsor

Full Name

Aalborg University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aalborg University Hospital","duties_or_roles":"Sponsor duties codes: 1, 8; contact email: gcp@rn.dk","organisation_type":"Hospital/Clinic/Other health care facility"}