Actively Recruiting
[68Ga]Ga-FAPI-46 Positron Emission Tomography (PET) Scan to Improve the Imaging of Pancreatic and Bile Duct Cancer
Led by Amsterdam UMC, location VUmc · Updated on 2023-07-24
63
Participants Needed
1
Research Sites
177 weeks
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
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.
CONDITIONS
Official 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
- Part A: pancreaticobiliary cancer with tumor size >20mm on CT
- Part B: primary pancreatic or pancreaticobiliary cancer with tumor size >20mm on CT and no treatment between scans
- Part C: pathologically proven pancreatic ductal adenocarcinoma eligible for neoadjuvant therapy before surgery
You will not qualify if you...
- Pregnant or lactating women
- Medical or psychiatric conditions preventing informed consent or study compliance
- Impaired renal function with creatinine clearance <60 mL/min
- White blood cell count less than 3.0 x 10^9/l
- Platelet count less than 100 x 10^9/l
- 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 ~90 minutes)
- Part A: contraindications for arterial cannula such as poor limb circulation, positive Allen test, severe atherosclerosis, or coagulation disorders
- Part C: not eligible for surgery after neoadjuvant chemotherapy
- Part C: confirmed metastatic disease after initial imaging and biopsy leading to treatment change
AI-Screening
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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
CONTACT
R
Rutger-Jan Swijnenburg, MD, PhD
CONTACT
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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