cholangiocarcinoma (bile duct cancer), pancreatic carcinoma (pancreatic cancer)
Conditions
Brief summary
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., 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.
Detailed description
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)., Percentage of potential change of therapy management enabled by [68Ga]Ga-FAPI-46 PET/CT, Percentage of agreement between different imaging modalities ([68Ga]Ga-FAPI-46 PET/CT and CT, MRI or FDG PET/CT), Sensitivity of response prediction based on the first [68Ga]Ga-FAPI-46 PET/CT, Accuracy of determining surgical resectability using [68Ga]Ga-FAPI-46 PET/CT., Correlation between [68Ga]Ga-FAPI-46 PET/CT signal to tumor regression (MDACC method), Diagnostic accuracy of incidental findings on [68Ga]Ga-FAPI-46 PET/CT
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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., 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 |
|---|---|
| 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)., Percentage of potential change of therapy management enabled by [68Ga]Ga-FAPI-46 PET/CT, Percentage of agreement between different imaging modalities ([68Ga]Ga-FAPI-46 PET/CT and CT, MRI or FDG PET/CT), Sensitivity of response prediction based on the first [68Ga]Ga-FAPI-46 PET/CT, Accuracy of determining surgical resectability using [68Ga]Ga-FAPI-46 PET/CT., Correlation between [68Ga]Ga-FAPI-46 PET/CT signal to tumor regression (MDACC method), Diagnostic accuracy of incidental findings on [68Ga]Ga-FAPI-46 PET/CT | — |
Countries
Netherlands