[68Ga]FAPI-46 PET Scan for Pancreatic Cancer
(FAPI-46 PDAC Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on any investigational drugs, you must not have taken them in the past 28 days.
What data supports the effectiveness of the treatment [68Ga]FAPI-46 for pancreatic cancer?
Research shows that [68Ga]FAPI-46 PET/CT scans can improve the detection and staging of pancreatic cancer compared to traditional methods, leading to changes in treatment plans for some patients. This suggests that [68Ga]FAPI-46 may be effective in providing more accurate information about the cancer's spread, which can help doctors make better treatment decisions.12345
Is [68Ga]FAPI-46 PET scan safe for humans?
How does the [68Ga]FAPI-46 PET scan treatment for pancreatic cancer differ from other treatments?
[68Ga]FAPI-46 PET scan is unique because it targets fibroblast activation protein (FAP), which is commonly found in the stroma of pancreatic tumors, allowing for improved tumor detection and staging compared to traditional imaging methods like [18F]FDG PET/CT. This can lead to more accurate diagnosis and potentially alter treatment plans for patients with pancreatic cancer.12348
What is the purpose of this trial?
This is a prospective, multi-center, single arm, open label, non-randomized study to evaluate the ability of \[68Ga\]FAPI-46 to detect FAP expressing cells in patients with resectable or borderline resectable PDAC. The \[68Ga\]FAPI-46 PET scans will be acquired after initial staging using institutional standard methods. If the participant is prescribed neoadjuvant therapy, a second \[68Ga\]FAPI-46 PET scan will be performed within 21 days prior to planned surgical resection. This will be followed by histopathology and IHC analyses and comparison to resected PDAC tumor specimens.
Eligibility Criteria
Adults over 18 with confirmed pancreatic ductal adenocarcinoma that's treatable by surgery or might be after neoadjuvant therapy. They must have had recent imaging and not started treatment yet. Excluded are pregnant individuals, those not using contraception, anyone needing urgent surgery, people with serious illnesses like kidney or liver failure, autoimmune diseases, known allergies to [68Ga]FAPI-46 components, or active infections.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Initial PET Scan
Participants undergo an initial [68Ga]FAPI-46 PET scan after staging using institutional standard methods
Neoadjuvant Therapy and Second PET Scan
If prescribed, participants receive neoadjuvant therapy followed by a second [68Ga]FAPI-46 PET scan within 21 days prior to planned surgical resection
Surgical Resection and Analysis
Participants undergo surgical resection followed by histopathology and IHC analyses
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- [68Ga]FAPI-46
Find a Clinic Near You
Who Is Running the Clinical Trial?
SOFIE
Lead Sponsor