18F‑FAPI PET/CT to detect metastatic pancreatic ductal adenocarcinoma
A Phase 3, Multicenter, Prospective Open-Label Study of the Diagnostic Performance of [¹⁸F]FAPI-74 PET/CT for the Detection of Metastatic Disease in Adults With Pancreatic Ductal Adenocarcinoma
This study will try a single [18F]FAPI‑74 PET/CT scan to see if it finds metastatic disease in adults with confirmed pancreatic ductal adenocarcinoma.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sofie Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 10 sites (Cerritos, California and 9 other locations) |
| Trial ID | NCT07217717 on ClinicalTrials.gov |
What this trial studies
This is a multi‑site, open‑label, non‑randomized phase 3 study in which participants with pathologically confirmed PDAC will receive one standardized dose of [18F]FAPI‑74 followed by PET/CT imaging. Imaging results will be compared against a composite standard‑of‑truth (SOT) panel to measure sensitivity and specificity for detecting metastatic disease. Standard‑of‑care procedures and interventions will be recorded for up to three months after the injection, and safety follow‑up will occur for 24–72 hours post‑dose. The overall study period from first patient screening to last patient follow‑up is expected to be about 24 months.
Who should consider this trial
Good fit: Adults (≥18) with pathologically confirmed PDAC who are undergoing staging for treatment planning, have ECOG performance status ≤2, and can obtain or have a contrast CT of chest/abdomen/pelvis within 21 days of the PET/CT are ideal candidates.
Not a fit: Patients with clear, unequivocal metastatic disease at enrollment that already rules out surgery or who cannot undergo PET/CT scanning are unlikely to benefit from this imaging procedure.
Why it matters
Potential benefit: If successful, this imaging method could improve detection of metastatic spread and help doctors choose the best treatment plan, including whether surgery is appropriate.
How similar studies have performed: Early‑phase and small clinical studies of FAPI PET tracers have shown promising lesion detection in PDAC compared with conventional imaging, but large definitive phase 3 evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female adults ≥ 18 years. * Participants with confirmed PDAC, undergoing staging evaluation for treatment planning. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2: * Provided signed, written informed consent obtained prior to any study-related procedures. * Participants are required to have a ceCT scan of chest, abdomen and pelvis as per standard clinical practice and practice guidelines either 21 days or less prior to entry or planned within 21 days of \[¹⁸F\]FAPI-74 administration. * For women who are not postmenopausal (two years of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use medically accepted, highly effective methods of contraception (e.g., hormonal implants, combined oral contraceptives, vasectomized partner , during the trial intervention period. Exclusion Criteria: * Unequivocal evidence of metastases at the time of enrollment that would preclude surgery as a treatment option. * Known hypersensitivity to \[¹⁸F\]FAPI-74. * Administration of another investigational therapeutic or diagnostic product within 30 days prior to \[¹⁸F\]FAPI-74 administration. * Prior administration of a radiopharmaceutical within 10 half-lives of that product from the time of \[¹⁸F\]FAPI-74 administration. * Previous cancer diagnosis (except basal cell carcinoma of the skin or in situ carcinoma of the cervix/uterus). Participants treated with curative intent and disease-free for more than 5 years are permitted. * Hepatic function: T. bili \>1.5X ULN or alk phos, ALT, or AST \>5X ULN * Renal function: GFR \< 30 mL/min * Pregnant or breast feeding (a negative pregnancy test is required in women of childbearing potential) * Inability to undergo the PET/CT scanning procedure. * Inflammatory bowel disease (Crohn's disease or ulcerative colitis) * Sarcoidosis * Treatment, including chemotherapy, radiation or surgery for curative intent of PDAC.
Where this trial is running
Cerritos, California and 9 other locations
- Helios CR Inc./RadNet — Cerritos, California, United States (Recruiting)
- Hoag Memorial Hospital — Irvine, California, United States (Recruiting)
- UCLA — Los Angeles, California, United States (Recruiting)
- Moffit Cancer Center — Tampa, Florida, United States (Recruiting)
- Indiana University Health University Hospital — Indianapolis, Indiana, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- UMass/Shields — Worcester, Massachusetts, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- Kettering — Kettering, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Alex Osipova
- Email: Alex.osipova@sofie.com
- Phone: 1-800-753-5368
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.