bile duct cancer cholangiocarcinoma pancreatic cancer pancreatic carcinoma
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 minimum 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 minimum 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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Pharmacokinetic analysis 1. To identify the optimal kinetic model to quantify [68Ga]Ga-FAPI-46 pharmacokinetics and tracer uptake. 2. To identify the most suitable simplified quantitative measurement as a surrogate for the full kinetic model. 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. 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part C: 1. 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). 2. Percentage of potential change of therapy management enabled by [68Ga]Ga-FAPI-46 PET/CT. 3. Percentage of agreement between different imaging modalities ([68Ga]Ga-FAPI-46 PET/CT and CT, MRI or FDG PET/CT). 4. Sensitivity of response prediction based on the first [68Ga]Ga-FAPI-46 PET/CT. 5. Accuracy of determining surgical resectability using [68Ga]Ga-FAPI-46 PET/CT. 6. Correlation between [68Ga]Ga-FAPI-46 PET/CT signal to tumor regression (MDACC method). 7. Diagnostic accuracy of incidental findings on [68Ga]Ga-FAPI-46 PET/CT. | — |
Countries
Netherlands
Outcome results
None listed