RECRUITINGINTERVENTIONAL

[68Ga]Ga-FAPI-46 Positron Emission Tomography (PET) Scan to Improve the Imaging of Pancreatic and Bile Duct Cancer

[68Ga]Ga-FAPI-46 Positron Emission Tomography in Pancreaticobiliary Cancers: a Pharmacokinetics, Repeatability and Diagnostic Accuracy Study

About This Trial

The goal of this clinical trial is to evaluate the clinical use of \[68Ga\]Ga-FAPI-46 PET (positron emission tomography)/CT (computed tomography) imaging in patients with pancreatic or bile duct cancer. The study consists of three parts and patients can only participate in one part of the study. The main questions the study aims to answer are: * In part A: What is the best timing and scanprotocol of a \[68Ga\]Ga-FAPI-46 PET/CT scan? * In part B: Are the results of the simplified scan protocol repeatable? * In part C: What is the accuracy of \[68Ga\]Ga-FAPI-46 PET/CT to detect pancreatic cancer and is it able to detect the effect of chemotherapy on pancreatic cancer lesions? Participants in this study will be asked to undergo the following: * In part A: participants will undergo 1 \[68Ga\]Ga-FAPI-46 PET/CT scan and will have 2 venous canullas and 1 arterial cannula placed. * In part B: participants will undergo 2 \[68Ga\]Ga-FAPI-46 PET/CT scans and will have a venous cannula placed for each scan. * In part C: participants will undergo 2 \[68Ga\]Ga-FAPI-46 PET/CT scans and will have a venous cannula placed for each scan.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients aged 18 years or older. - Before patient registration, written willing to sign a consent form must be given according to ICH/GCP, and national/local regulations. - Additional Part A: patients with pancreaticobiliary cancer (pancreatic, intra- or extrahepatic cholangiocarcinoma) and a tumor size of \>20mm on CT. - Additional Part B: patients with primary pancreatic (or pancreaticobiliary) cancer (depending on the results of part A) and a tumor size of \>20mm on CT. No treatment may be given in between the two scans. - Additional Part C: patients with pathologically proven pancreatic ductal adenocarcinoma, eligible for neoadjuvant therapy before surgical resection. Who Should NOT Join This Trial: - Women who are pregnant and/or lactating. - Medical or psychiatric conditions that compromise the patient's ability to give willing to sign a consent form. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. - Impaired renal function (creatinine clearance \<60 mL/min according to the Cockcroft-Gault equation. - Leucocytes (WBC) ≤3.0 x 10\^9/l - Platelets ≤ 100 x 10\^9 /l - Hemoglobin ≤ 6 mmol/l - Known hypersensitivity to drugs comparative to \[68Ga\]Ga-FAPI-46, or any of the excipients of \[68Ga\]Ga-FAPI-46. - 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)). Additional Part A: • Contra-indication for arterial cannula (e.g. inadequate circulation of extremity, positive Allen test, severe atherosclerosis, coagulant disorder (INR \>1.4 or APTT \>50)). Additional Part C: - Not eligible for surgery after neoadjuvant chemotherapy. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Patients aged 18 years or older. * Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations. * Additional Part A: patients with pancreaticobiliary cancer (pancreatic, intra- or extrahepatic cholangiocarcinoma) and a tumor size of \>20mm on CT. * Additional Part B: patients with primary pancreatic (or pancreaticobiliary) cancer (depending on the results of part A) and a tumor size of \>20mm on CT. No treatment may be given in between the two scans. * Additional Part C: patients with pathologically proven pancreatic ductal adenocarcinoma, eligible for neoadjuvant therapy before surgical resection. Exclusion Criteria: * Women who are pregnant and/or lactating. * 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. * Impaired renal function (creatinine clearance \<60 mL/min according to the Cockcroft-Gault equation. * Leucocytes (WBC) ≤3.0 x 10\^9/l * Platelets ≤ 100 x 10\^9 /l * Hemoglobin ≤ 6 mmol/l * Known hypersensitivity to drugs comparative to \[68Ga\]Ga-FAPI-46, or any of the excipients of \[68Ga\]Ga-FAPI-46. * 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)). Additional Part A: • Contra-indication for arterial cannula (e.g. inadequate circulation of extremity, positive Allen test, severe atherosclerosis, coagulant disorder (INR \>1.4 or APTT \>50)). 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.

Treatments Being Tested

DIAGNOSTIC_TEST

[68Ga]Ga-FAPI-46 PET/CT

one or two \[68Ga\]Ga-FAPI-46 PET/CT scan(s)

Locations (1)

Amsterdam UMC, location VUmc

Amsterdam, North Holland, Netherlands