RECRUITING Phase 3 ClinicalTrials.gov

Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.

Sponsor: SOFIE • ClinicalTrials.gov ID: NCT07217704

Registry updated: 2026-10-19

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Description

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 gastric, gastroesophageal junction or esophageal cancer. 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.

Interventions

[18F]FAPI-74 PET/CT (Drug)
\[18F\]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 gastric or esophageal cancers.

Eligibility criteria

Inclusion Criteria: * Male and female adults ≥ 18 years. * Participants with confirmed gastric, esophageal or gastroesophageal malignancy undergoing staging evaluation for treatment planning. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2. * Provided signed, written informed consent 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 diagnostic or therapeutic 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 (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 currently 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, ulcerative colitis) * Sarcoidosis * Treatment, including chemotherapy, radiation, immunotherapy or surgery for curative intent of Gastroesophageal cancers

Conditions

Esophageal Cancer Gastric Cancer (GC) Gastroesophageal Junction

Locations

Helios CR Inc./RadNet — Cerritos, California, United States
City of Hope National Cancer Center — Duarte, California, United States
Hoag Memorial Hospital — Irvine, California, United States
UCLA — Los Angeles, California, United States
Stanford University — Stanford, California, United States
Impression Imaging — Coral Springs, Florida, United States
Mayo Clinic Jacksonville — Jacksonville, Florida, United States
Moffit Cancer Center — Tampa, Florida, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago, Illinois, United States
Indiana University Health University Hospital — Indianapolis, Indiana, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
UMass/Shields — Worcester, Massachusetts, United States
Mayo Clinic Rochester — Rochester, Minnesota, United States
Icahn School of Medicine at Mount Sinai — New York, New York, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
Cleveland Clinic — Cleveland, Ohio, United States
Kettering — Kettering, Ohio, United States
University of Pennsylvania, Perelman School of Medicine — Philadelphia, Pennsylvania, United States
Medical College of Wisconsin — Milwaukee, Wisconsin, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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