[AL[18F]F]FAPI-74 for Cholangiocarcinoma

Inclusion criteria

• {"criterion_text":"- Patient is scheduled for explorative laparoscopy or laparotomy for suspicion of proximal cholangiocarcinoma (perihilar, intrahepatic and gall bladder cholangiocarcinoma)"}
• {"criterion_text":"- Tumor is regarded as resectable based on preoperative CT and MRI"}
• {"criterion_text":"- Patient is 18 years or older and is able to give informed consent"}

Exclusion criteria

• {"criterion_text":"- Previous abdominal surgery or chemotherapy"}
• {"criterion_text":"- Patient had FDG PET-CT in addition to preoperative CT and MRI"}
• {"criterion_text":"- Contra-indication for performing PET-CT"}
• {"criterion_text":"- Indication for FDG PET-CT"}
• {"criterion_text":"- Pregnancy or lactation, for the latter, temporary discontinuation may be considered"}
• {"criterion_text":"- Known allergic reaction to therapeutic radiopharmaceuticals"}
• {"criterion_text":"- Inability to lie still on the back for the duration of PET-CT"}
• {"criterion_text":"- Impaired renal function, defined as eGFR (MDRD) <25 ml/min/1,73 m2. An exception can be made in consultation with the treating physician."}
• {"criterion_text":"- Any (other) condition, disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that may affect the interpretation of the results, or which might contribute substantially to the patient's experience of study burden (such as non-suppressible claustrophobia)"}

Primary endpoints

• {"endpoint_text":"- sensitivity, specificity, positive predictive value, negative predictive value","definition_or_measurement_approach":"Assess diagnostic accuracy of [18F]F-FAPI PET-CT in addition to standard preoperative imaging; measured as sensitivity, specificity, positive predictive value, negative predictive value."}

Secondary endpoints

• {"endpoint_text":"- True change and virtual change","definition_or_measurement_approach":"As stated in protocol: 'True change and virtual change' (no further measurement approach specified in provided source)."}
• {"endpoint_text":"- Number of times readers’ conclusions differed","definition_or_measurement_approach":"Inter-reader variability between nuclear medicine specialists as stated (no further measurement approach specified in provided source)."}
• {"endpoint_text":"- Cost-effectiveness analysis, budget impact analysis (BIA), sector costs, societal costs, health-related quality of life (HRQoL)","definition_or_measurement_approach":"Economic evaluations and HRQoL assessment as stated (no further measurement approach specified in provided source)."}
• {"endpoint_text":"- Number of additional significant findings","definition_or_measurement_approach":"Count of additional significant findings on [18F]F-FAPI PET-CT as stated (no further measurement approach specified in provided source)."}
• {"endpoint_text":"- Number of days between date of first imaging (CT/MRI) and starting date of chemotherapy, palliative therapy or surgical resection","definition_or_measurement_approach":"Measured as days between first imaging date and start date of subsequent therapy or resection as stated."}
• {"endpoint_text":"- The incidence and severity of AEs and SAEs according to CTCAEv5","definition_or_measurement_approach":"Adverse events and serious adverse events graded and reported according to CTCAEv5 as stated."}
• {"endpoint_text":"- Volume of interest (VOI), time to peak(TTP), K1 and K2, standardize uptake value (SUV), tumor-to-background ratio (TBR)","definition_or_measurement_approach":"Imaging-derived quantitative measures (VOI, TTP, K1, K2, SUV, TBR) as stated (no further measurement approach specified in provided source)."}

Netherlands

Earliest CTIS Part Ii Submission Date

15-02-2024

Latest Decision Or Authorization Date

16-09-2024

Processing Time Days

214

Number Of Sites

3

Number Of Participants

81

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands