Status:
COMPLETED
Study of [68Ga]FAPI-46 PET in Patients With Pancreatic Ductal Carcinoma
Lead Sponsor:
SOFIE
Conditions:
PDAC - Pancreatic Ductal Adenocarcinoma
FAP
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 re...
Eligibility Criteria
Inclusion
- Pathologically confirmed pancreatic ductal adenocarcinoma
- Treatment-naïve
- Staged as resectable or borderline-resectable
- Planned to undergo surgical resection or to receive neoadjuvant therapy (i.e., chemotherapy, radiation therapy, or combination) and subsequent possible surgical resection
- Anatomic imaging (e.g., CT, MRI) obtained within ≤ 28 days of consent
- Age ≥ 18 years
- Completed informed consent as determined per the IRB of record
Exclusion
- Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential
- Declining to use effective contraceptive methods during the study (for individuals of child-producing potential)
- Need for emergent surgery that would be delayed by participation
- Bacterial, viral, or fungal infections requiring systemic therapy
- Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney failure, liver failure, systemic or local inflammatory or autoimmune diseases or other conditions) that in the opinion of the investigator, physician of record and/or Sofie could compromise patient safety and/or protocol objectives.
- Known diagnosis of autoimmune disorders
- Patients receiving any other investigational agent within the past 28 days
- Breastfeeding. Note: nursing parents are allowed if the potential participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the \[68Ga\]FAPI-46 injection.
- Known hypersensitivity to any excipients used in \[68Ga\]FAPI-46:
- trace amounts of sodium acetate sodium ascorbate and/or hydrochloric acid
Key Trial Info
Start Date :
May 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2025
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT05262855
Start Date
May 2 2022
End Date
November 4 2025
Last Update
November 6 2025
Active Locations (4)
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1
University of California Los Angeles (UCLA) Health
Los Angeles, California, United States, 90095
2
BAMF Health
Grand Rapids, Michigan, United States, 49503
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
4
NYU Langone Health
New York, New York, United States, 10016