GALLIUM (68GA) CHLORIDE for Cholangiocarcinoma | Pancreatic carcinoma (including pancreatic ductal adenocarcinoma)

Inclusion criteria

• {"criterion_text":"- Patients aged 18 years or older"}
• {"criterion_text":"- Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations."}
• {"criterion_text":"- Additional Part A: patients with pancreaticobiliary cancer (pancreatic, intra- or extrahepatic cholangiocarcinoma) and a minimum tumor size of 20mm on CT."}
• {"criterion_text":"- Additional Part B: patients with primary pancreatic (or pancreaticobiliary) cancer (depending on the results of part A) with a minimum tumor size of 20mm on CT. No treatment may be given in between the two scans."}
• {"criterion_text":"- Additional Part C: patients with pathologically proven pancreatic ductal adenocarcinoma, eligible for neoadjuvant therapy before surgical resection."}

Exclusion criteria

• {"criterion_text":"- Women who are pregnant and/or lactating."}
• {"criterion_text":"- Additional Part C: - Not eligible for surgery after neoadjuvant chemotherapy. - If based on the first FAPI-46 PET/CT, there is a suspicion of metastatic disease the images will be discussed in the multidisciplinary meeting and one additional imaging modality (and a biopsy, if this would lead to a change of treatment strategy) can be used to confirm the suspicion. If metastatic disease is confirmed the patient will be excluded."}
• {"criterion_text":"- Medical or psychiatric conditions that compromise the patient's ability to give informed consent. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule."}
• {"criterion_text":"- Impaired renal function (creatinine clearance ≤60 mL/min according to the Cockcroft-Gault equation"}
• {"criterion_text":"- Leucocytes (WBC) ≤3.0 x 109/l"}
• {"criterion_text":"- Platelets ≤ 100 x 109 /l"}
• {"criterion_text":"- Hemoglobin ≤ 6 mmol/l"}
• {"criterion_text":"- Known hypersensitivity to drugs comparative to [68Ga]Ga-FAPI-46, or any of the excipients of [68Ga]Ga-FAPI-46."}
• {"criterion_text":"- Inability to undergo PET/CT scanning (e.g. claustrophobia, weight limits or inability to tolerate lying for the duration of a PET/CT scan (~90 min)"}
• {"criterion_text":"- Additional Part A: Contra-indication for arterial cannulation (e.g. inadequate circulation of extremity, positive Allen test, severe atherosclerosis, coagulant disorder (INR >1.4 or APTT >50))"}

Primary endpoints

• {"endpoint_text":"- Part A: Pharmacokinetic analysis 1. The optimal kinetic model to quantify [68Ga]Ga-FAPI-46 pharmacokinetics and tracer uptake. 2. The most suitable simplified quantitative measurement, as a surrogate for the full kinetic model.","definition_or_measurement_approach":"Identify optimal kinetic model for [68Ga]Ga-FAPI-46 pharmacokinetics and determine a simplified quantitative measurement as surrogate for full kinetic model (pharmacokinetic analysis)."}
• {"endpoint_text":"- Part B: Test-retest variation study 1. The daily variability (average percentage of difference) of the preferred simplified method for quantification of [68Ga]Ga-FAPI-46.","definition_or_measurement_approach":"Assess test-retest repeatability: compute daily variability (average percentage difference) of the preferred simplified quantification method derived from Part A."}
• {"endpoint_text":"- Part C: Diagnostic accuracy 1. Per lesion analysis of diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT. 2. Diagnostic accuracy of response monitoring using [68Ga]Ga-FAPI-46 PET/CT.","definition_or_measurement_approach":"Per-lesion diagnostic accuracy analysis versus reference standards; assess diagnostic accuracy of response monitoring using PET/CT (comparison to clinical/surgical/pathologic outcomes as applicable)."}

Secondary endpoints

• {"endpoint_text":"- Percentage of agreement between tumor uptake on the [68Ga]Ga- FAPI-46 PET/CT scan, histopathologic evidence of tumor, and the expression of FAP (IHC).","definition_or_measurement_approach":"Measure percent agreement between PET uptake, histopathology, and FAP IHC expression."}
• {"endpoint_text":"- Percentage of potential change of therapy management enabled by [68Ga]Ga-FAPI-46 PET/CT","definition_or_measurement_approach":"Determine proportion of cases in which PET/CT findings would lead to a potential change in therapy management."}
• {"endpoint_text":"- Percentage of agreement between different imaging modalities ([68Ga]Ga-FAPI-46 PET/CT and CT, MRI or FDG PET/CT)","definition_or_measurement_approach":"Assess percent agreement between [68Ga]Ga-FAPI-46 PET/CT and other imaging modalities (CT, MRI, FDG PET/CT)."}
• {"endpoint_text":"- Sensitivity of response prediction based on the first [68Ga]Ga-FAPI-46 PET/CT","definition_or_measurement_approach":"Calculate sensitivity of early PET/CT for predicting treatment response."}
• {"endpoint_text":"- Accuracy of determining surgical resectability using [68Ga]Ga-FAPI-46 PET/CT.","definition_or_measurement_approach":"Assess accuracy of PET/CT in determining surgical resectability compared to surgical/pathologic outcomes."}
• {"endpoint_text":"- Correlation between [68Ga]Ga-FAPI-46 PET/CT signal to tumor regression (MDACC method)","definition_or_measurement_approach":"Correlate PET/CT signal metrics with tumor regression measured by the MDACC method."}
• {"endpoint_text":"- Diagnostic accuracy of incidental findings on [68Ga]Ga-FAPI-46 PET/CT","definition_or_measurement_approach":"Evaluate diagnostic accuracy for incidental findings detected on PET/CT."}

Netherlands

Earliest CTIS Part Ii Submission Date

24-09-2024

Latest Decision Or Authorization Date

26-09-2024

Processing Time Days

2

Number Of Sites

1

Number Of Participants

63

Primary sponsor

Full Name

Stichting Amsterdam UMC

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"Cancer Center Amsterdam (CCA)","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"KWF kankerbestrijding","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"Cholangiocarcinoma Foundation Research Fellowship","duties_or_roles":"Monetary support","organisation_type":""}