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Clinical Trials in the USA / NCT07217717
Recruiting Phase 3

Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Pancreatic Ductal Adenocarcinoma (PDAC)

NCT07217717 · tracked via the Priya Life Science USA tracker
Sponsor
SOFIE
Phase
Phase 3
Started
2025-12-11
Last updated
2026-09-15

Condition(s) studied

Pancreatic Ductal Adenocarcinoma (PDAC)

Investigational drug(s) / intervention(s)

[18F]FAPI-74 PET/CT

[18F]FAPI-74 PET/CT: \[18F\]FAPI-74 is a radioactive diagnostic agent indicated for use with Positron Emission Tomography (PET) imaging for the detection of Fibroblast Activation Protein (FAP) positive cancer cells and cancer-associated fibroblasts (CAF) in patients with pancreatic ductal adenocarcinoma.

Study summary

This is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of \[¹⁸F\]FAPI-74 PET/CT in the detection of metastatic disease in individuals with pathologically confirmed pancreatic ductal adenocarcinoma. Following screening, using a standardized administration protocol and dose, participants will undergo \[¹⁸F\]FAPI-74 PET/CT screening. SOC procedures and interventions will be captured during 3 months +/-14 days post injection. The primary objective is to evaluate the sensitivity and specificity of such \[¹⁸F\]FAPI-74 PET/CT using a composite SOT panel. The maximum expected duration of the trial is approximately 24 months from first patient screening to last patient SOC follow up. The participants will be followed-up for safety for 24 to 72 hours after the dose of \[¹⁸F\]FAPI-74 PET/CT.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
Helios CR Inc./RadNet Cerritos California Recruiting
City of Hope National Cancer Center Duarte California Recruiting
Hoag Memorial Hospital Irvine California Recruiting
UCLA Los Angeles California Recruiting
Stanford University Stanford California Recruiting
Moffit Cancer Center Tampa Florida Recruiting
Indiana University Health University Hospital Indianapolis Indiana Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
UMass/Shields Worcester Massachusetts Recruiting
Mayo Clinic Rochester Rochester Minnesota Recruiting
Icahn School of Medicine at Mount Sinai New York New York Not Yet Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
Kettering Kettering Ohio Recruiting
University of Pennsylvania, Perelman School of Medicine Philadelphia Pennsylvania Recruiting
Medical College of Wisconsin Milwaukee Wisconsin Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07217717 on ClinicalTrials.gov ↗ ← All trials in the USA