Imaging cancer-associated fibroblasts in localized pancreatic cancer
Quantitative In Vivo 68Ga-Fibroblast-Activation-Protein-Inhibitors (FAPI)-46 PET Imaging of Cancer-Associated Fibroblasts (CAFs) in Pancreatic Ductal Adenocarcinoma (PDA)
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.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05518903 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with biopsy-proven localized pancreatic ductal adenocarcinoma who are expected to undergo surgical resection.
Not a fit: Patients with metastatic pancreatic cancer or those requiring emergency surgery may not benefit from this study.
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 performed: Other studies have shown promise in using similar imaging techniques for cancer detection, but this specific approach is novel.
Eligibility criteria
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 this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Ajit H. Goenka, M.D. — Mayo Clinic in Rochester
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.