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[68Ga]Ga-FAPI-46 positron emission tomography in pancreatobiliary cancers: a pharmacokinetics, repeatability and diagnostic accuracy study. (PANSCAN-1)

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516486-36-00
Enrollment
63
Registered
2024-09-26
Start date
2025-03-24
Completion date
Unknown
Last updated
2024-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cholangiocarcinoma (bile duct cancer), pancreatic carcinoma (pancreatic cancer)

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

Stichting Amsterdam UMC
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026