Actively Recruiting
[68Ga]Ga-FAPI-46 Positron Emission Tomography in Pancreaticobiliary Cancers: a Pharmacokinetics, Repeatability and Diagnostic Accuracy Study
Led by Amsterdam UMC, location VUmc · Updated on 2023-07-24
63
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Amsterdam UMC, location VUmc
Lead Sponsor
D
Dutch Cancer Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical use of [68Ga]Ga-FAPI-46 PET/CT imaging in patients with pancreatic or bile duct cancer. This study aims to find the best timing and scan protocol, test the repeatability of the scan results, and assess the accuracy of this imaging method to detect pancreatic cancer and monitor chemotherapy effects. The study is divided into three parts, with each participant joining only one part. In part A, participants will have one [68Ga]Ga-FAPI-46 PET/CT scan and receive two venous cannulas and one arterial cannula. Part B involves two scans with a venous cannula for each. Part C includes two scans with venous cannulas and focuses on patients eligible for neoadjuvant therapy before surgery. The study evaluates the tracer's pharmacokinetics, repeatability, and diagnostic accuracy. Participants will undergo PET/CT scans and have cannulas placed as needed. Researchers will collect blood activity measurements, plasma to blood ratios, and semi-quantitative tracer uptake data. They will assess repeatability, diagnostic accuracy, and therapy response monitoring over three months. Safety and agreement between imaging and pathology will also be evaluated during and after scans.
CONDITIONS
Brief Title
[68Ga]Ga-FAPI-46 Positron Emission Tomography (PET) Scan to Improve the Imaging of Pancreatic and Bile Duct Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Written informed consent given according to regulations
- For Part A: pancreaticobiliary cancer with tumor size greater than 20mm on CT
- For Part B: primary pancreatic or pancreaticobiliary cancer with tumor size greater than 20mm on CT, no treatment between scans
- For Part C: pathologically confirmed pancreatic ductal adenocarcinoma eligible for neoadjuvant therapy before surgery
You will not qualify if you...
- Women who are pregnant or breastfeeding
- Medical or psychiatric conditions preventing informed consent or study compliance
- Impaired renal function with creatinine clearance less than 60 mL/min
- Low white blood cell count (less than 3.0 x 10^9/l)
- Low platelet count (less than 100 x 10^9/l)
- Low hemoglobin (less than 6 mmol/l)
- Known allergy to [68Ga]Ga-FAPI-46 or its components
- Inability to undergo PET/CT scanning (e.g., claustrophobia, weight limits, inability to lie still for about 90 minutes)
- For Part A: contraindications for arterial cannula (such as poor limb circulation, positive Allen test, severe atherosclerosis, blood clotting disorders)
- For Part C: not eligible for surgery after neoadjuvant chemotherapy or confirmed metastatic disease after additional imaging and biopsy if needed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants undergo one or two [68Ga]Ga-FAPI-46 PET/CT scans to assess tumor lesions and monitor therapeutic response.
1 to 2 visits depending on study phase
Trial Site Locations
Total: 1 location
1
Amsterdam UMC, location VUmc
Amsterdam, North Holland, Netherlands, 1081 HV
Actively Recruiting
Research Team
R
Rutger B Henrar, MD
R
Rutger-Jan Swijnenburg, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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