Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Imaging cancer-associated fibroblasts in localized pancreatic cancer

Official title: Quantitative In Vivo 68Ga-Fibroblast-Activation-Protein-Inhibitors (FAPI)-46 PET Imaging of Cancer-Associated Fibroblasts (CAFs) in Pancreatic Ductal Adenocarcinoma (PDA)

Run by Mayo Clinic · NCT05518903 · Data updated 2026-11-12

This study is testing a special type of scan to see if it can help find certain cells in patients with localized pancreatic cancer and predict how well they will do after surgery.

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Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment130 (estimated)
SponsorMayo Clinic
Academic / other
Locations1 site (Rochester, Minnesota)
StatusRecruiting
StartedNovember 15, 2022
Main results expectedJune 30, 2027
Study endsJune 30, 2028
Registry record updatedAugust 10, 2026
Trial IDNCT05518903 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults over 18 with biopsy-proven localized pancreatic ductal adenocarcinoma who are expected to undergo surgical resection.

Probably not a fit

Patients with metastatic pancreatic cancer or those requiring emergency surgery may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial evaluates the effectiveness of 68Ga-FAPI-46 PET/CT scans in detecting cancer-associated fibroblasts (CAFs) in patients with localized pancreatic ductal adenocarcinoma (PDA). The study aims to determine the sensitivity and specificity of this imaging technique and to develop a model predicting surgical outcomes based on PET biomarkers. Patients will receive an intravenous injection of 68Ga-FAPI-46, followed by PET/CT scans at baseline and during follow-up visits. The trial will track patient outcomes for five years after treatment.

Why it matters

Potential benefit: If successful, this study could improve the accuracy of imaging for localized pancreatic cancer, potentially leading to better surgical outcomes.

How similar studies have gone: Other studies have shown promise in using similar imaging techniques for cancer detection, but this specific approach is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 Criteria:

* Hypersensitivity to any excipients in 68Ga-FAPI-46
* Require emergency surgery
* Non-PDA histology on biopsy
* Histopathologically proven metastatic PDA
* Pregnant or lactating women

Where it's running

  • Mayo Clinic in Rochester
    Rochester, Minnesota, United States
    Recruiting

Study contacts

  • Principal investigator: Ajit H. Goenka, M.D. — Mayo Clinic in Rochester

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.