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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 Gastric or Esophageal Cancer
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Helios CR Inc./RadNet
Cerritos, California, United States
Hoag Memorial Hospital
Irvine, California, United States
UCLA
Los Angeles, California, United States
Moffit Cancer Center
Tampa, Florida, United States
Indiana University Health University Hospital
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
UMass/Shields
Worcester, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Kettering
Kettering, Ohio, United States
Start Date
November 14, 2025
Primary Completion Date
August 30, 2027
Completion Date
August 30, 2027
Last Updated
March 16, 2026
200
ESTIMATED participants
[18F]FAPI-74 PET/CT
DRUG
Lead Sponsor
SOFIE
NCT04704661
NCT04674267
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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