Investigational Scan for Localized Pancreatic Cancer

This study is testing a new type of scan, called 68Ga-FAPI-46 PET/CT, for people with pancreatic cancer that has not spread (localized pancreatic ductal adenocarcinoma). This scan helps doctors see special cells called cancer-associated fibroblasts (CAFs) that are often found near tumors. The 68Ga-FAPI-46 is a special chemical that attaches to these CAFs, making them visible on the PET/CT scan. The goal is to see how well this scan can find and measure these CAFs, and how the scan results relate to other markers of the cancer. You might be able to join if you are an adult with newly diagnosed localized pancreatic cancer that doctors plan to remove with surgery, and you are generally in good health. The study aims to understand if this scan can help predict how well treatments will work. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 130 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive 68Ga-FAPI-46 intravenously, then have PET/CT scans at the start, up to two more scans during standard treatment, and one scan before surgery if applicable.
Compensation
Not stated in the trial record.
Follow-up
After your study treatment, you would be followed for up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05518903

Investigational Scan (68Ga-FAPI-46 PET/CT) for Imaging of Cancer-Associated Fibroblasts for Localized Pancreatic Ductal Adenocarcinoma

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
Mayo Clinic
~130 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:Computed TomographyGallium Ga 68 FAPi-46Positron Emission Tomography

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Diagnostic performance of fibroblast-activation-protein-inhibitors (FAPI) positron emission tomography (PET) for detection and quantification of cancer-associated fibroblasts (CAFs) in pancreatic ductal adenocarcinoma (PDA)
Measured over Up to 5 years
+5 more outcomes measured
Localized Pancreatic Adenocarcinoma
Resectable Pancreatic Ductal Adenocarcinoma
Stage 0 Pancreatic Cancer AJCC v8
Stage I Pancreatic Cancer AJCC v8
Stage IIA Pancreatic Cancer AJCC v8

NCT05518903

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic in Rochester

    Rochester, Minnesotastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Ajit H. Goenka, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

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Eligibility criteria

Inclusion

Adults \> 18 years (yrs.) with treatment-naive biopsy-proven PDA or with findings diagnostic for PDA on baseline imaging (CT, MRI, or PET)
Localized disease expected to undergo surgical resection following neoadjuvant therapy (NAT)
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Ability to provide informed consent

Exclusion

Hypersensitivity to any excipients in 68Ga-FAPI-46
Require emergency surgery
Non-PDA histology on biopsy
Histopathologically proven metastatic PDA
Pregnant or lactating women
  • Diagnostic performance of fibroblast-activation-protein-inhibitors (FAPI) positron emission tomography (PET) for detection and quantification of cancer-associated fibroblasts (CAFs) in pancreatic ductal adenocarcinoma (PDA)Up to 5 years

    Using surgical immunohistochemistry (IHC) as gold standard.

  • Relationship between 68Ga-FAPI-46 PET metrics in PDAUp to 5 years

    Relationship between 68Ga-FAPI-46 PET metrics assessed

  • Relationship between 68Ga-FAPI-46 PET metrics and cancer antigen 19-9 (CA19-9) biomarkers in PDAUp to 5 years

    Relationship between 68Ga-FAPI-46 PET metrics and cancer antigen 19-9 (CA19-9) being assessed.

  • Relationship between 68Ga-FAPI-46 PET metrics and Kirsten rat sarcoma (KRAS), circulating tumor deoxyribonucleic acid (ctDNA) biomarkers in PDAUp to 5 years

    Relationship between 68Ga-FAPI-46 PET metrics and Kirsten rat sarcoma (KRAS), circulating tumor deoxyribonucleic acid (ctDNA) being assessed.

  • Relationship between 68Ga-FAPI-46 PET metrics and staging examinations in PDAUp to 5 years

    Relationship between 68Ga-FAPI-46 PET metrics and fludeoxyglucose F-18 (FDG) PET staging exam being assessed.

  • Relationship between 68Ga-FAPI-46 PET metrics and staging examinations in PDAUp to 5 years

    Relationship between 68Ga-FAPI-46 PET metrics and magnetic resonance imaging (MRI) staging exam being assessed.