RecruitingNot ApplicableNCT05957250

[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


Sponsor

Amsterdam UMC, location VUmc

Enrollment

63 participants

Start Date

Feb 3, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a special PET scan using a radioactive tracer called FAPI-46 can better detect and monitor pancreatic and bile duct cancers compared to standard imaging. The tracer targets a protein found in the tissue surrounding tumors. **You may be eligible if...** - You are 18 or older with a pancreatic or bile duct (pancreaticobiliary) cancer with a tumor larger than 2 cm on CT scan - Depending on the study part, you may need to be eligible for neoadjuvant (pre-surgery) chemotherapy **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have severe kidney impairment (low kidney filtration rate) - You have significantly low blood counts or hemoglobin - You are allergic to the study tracer or similar compounds - You are unable to lie still for approximately 90 minutes in a PET/CT scanner (e.g., due to claustrophobia or weight limits) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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NCT05957250


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