Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.
Start Date
11/14/2025
Completion Date
8/30/2027
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 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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
[18F]FAPI-74 PET/CT
Conditions
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 44194
United States
Kettering
Kettering, Ohio 45429
United States
University of Pennsylvania, Perelman School of Medicine
Philadelphia, Pennsylvania 19104
United States