GOZETOTIDE ALF-18 for Hepatocellular carcinoma

Inclusion criteria

• {"criterion_text":"- Willing and mentally legally capable to provide written informed consent"}
• {"criterion_text":"- 18 years of age or older"}
• {"criterion_text":"- - One of the following clinical scenario’s: • New diagnosis of HCC, confirmed either by biopsy or imaging using EASL/AASLD criteria, with a high risk of metastases indicated by portal invasion or a primary lesion of >5cm diameter. • Known diagnosis of HCC that requires restaging due to unexplained elevated AFP tumor markers, known metastases, impending initiation of immunotherapy, or being on the waiting list for a liver transplant."}
• {"criterion_text":"- Have either planned or recently undergone (within the past 4 weeks) both F-18 FDG PET/CT and F-18 Choline PET/CT scans as part of their diagnostic or staging workup for one of the above indications."}

Exclusion criteria

• {"criterion_text":"- Known active malignancy other than hepatocellular carcinoma."}
• {"criterion_text":"- History of prostate cancer"}
• {"criterion_text":"- Active pregnancy"}
• {"criterion_text":"- Possible pregnancy and refusal of urine pregnancy test"}

Primary endpoints

• {"endpoint_text":"- Per-lesion detection rate of F-18 PSMA-11 PET/CT, 60-90 minutes post-injection.","definition_or_measurement_approach":"Per-lesion detection rate measured by F-18 PSMA-11 PET/CT imaging performed 60-90 minutes after tracer injection."}

Secondary endpoints

• {"endpoint_text":"- Overall Survival (OS) and Progression-Free Survival (PFS): Measured among subjects with PSMA-avid, FDG-avid, and Choline-avid HCC lesions, measured after completion of the 2 year follow-up for all patients.","definition_or_measurement_approach":"OS and PFS measured among subjects stratified by tracer avidity and assessed after completion of a 2-year follow-up period for all patients."}
• {"endpoint_text":"- Tumor-to-Background Ratio: Assessed for intrahepatic HCC lesions 60-90 minutes post-injection using F-18 PSMA-11 PET/CT.","definition_or_measurement_approach":"Tumor-to-background ratio calculated for intrahepatic lesions on F-18 PSMA-11 PET/CT images acquired 60-90 minutes post-injection."}
• {"endpoint_text":"- Standard Uptake Value (SUV) Parameters: Analyzed for all HCC lesions detected 60-90 minutes post-injection with F-18 PSMA-11 PET/CT.","definition_or_measurement_approach":"SUV parameters (as defined in protocol) measured for all detected HCC lesions on F-18 PSMA-11 PET/CT images acquired 60-90 minutes post-injection."}
• {"endpoint_text":"- Proportion of subjects with Metastatic HCC: Comparison between those detected by F-18 PSMA-11 PET/CT, F-18 FDG PET, and F-18 Choline PET, 60-90 minutes post-injection.","definition_or_measurement_approach":"Proportion of subjects with metastatic disease detected by each imaging modality compared; assessments based on imaging performed 60-90 minutes post-injection."}

Belgium

Earliest CTIS Part Ii Submission Date

30-07-2024

Latest Decision Or Authorization Date

23-08-2024

Processing Time Days

24

Number Of Sites

1

Number Of Participants

32

Primary sponsor

Full Name

Universitair Ziekenhuis Gent

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium

Third parties

• {"country":"","full_name":"Kom Op Tegen Kanker","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"University Hospital Ghent","duties_or_roles":"Monetary support","organisation_type":""}