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NCT07217717PHASE3Recruiting

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

SOFIE

Start Date

12/11/2025

Completion Date

12/31/2027

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

[18F]FAPI-74 PET/CT

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Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Locations

Helios CR Inc./RadNet

Cerritos, California 90703

United States

City of Hope National Cancer Center

Duarte, California 91010

United States

Hoag Memorial Hospital

Irvine, California 92618

United States

UCLA

Los Angeles, California 90095

United States

Stanford University

Stanford, California 94305

United States

Moffit Cancer Center

Tampa, Florida 33612

United States

Indiana University Health University Hospital

Indianapolis, Indiana 46202

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

UMass/Shields

Worcester, Massachusetts 01655

United States

Mayo Clinic Rochester

Rochester, Minnesota 55905

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Kettering

Kettering, Ohio 45429

United States

University of Pennsylvania, Perelman School of Medicine

Philadelphia, Pennsylvania 19104

United States