18F‑FAPI PET/CT to detect metastatic pancreatic ductal adenocarcinoma

Is this trial a fit for you?

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

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.

Why it matters

Who can join: the full rules

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 it's running

• Helios CR Inc./RadNet
  Cerritos, California, United States Recruiting
• City of Hope National Cancer Center
  Duarte, California, United States Recruiting
• Hoag Memorial Hospital
  Irvine, California, United States Recruiting
• UCLA
  Los Angeles, California, United States Recruiting
• Stanford University
  Stanford, California, United States Recruiting
• Impression Imaging
  Coral Springs, Florida, United States Recruiting

Study contacts

• Study coordinator: Alex Osipova
• Email: Alex.osipova@sofie.com
• Phone: 1-800-753-5368

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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.