Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.
Condition(s) studied
Investigational drug(s) / intervention(s)
[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 gastric or esophageal cancers.
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 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
Primary outcome measure(s)
- Sensitivity and specificity for detection of distant metastatic disease (M1) using a composite SOT as reference — From enrollment to the end of treatment after 3 month follow up
To evaluate the diagnostic performance of \[¹⁸F\]FAPI-74 in determining the presence or absence of metastatic disease (M1) in individuals with pathologically confirmed gastric, gastroesophageal junction or esophageal cancers, compared to a composite SOT
Trial sites (19)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
| Impression Imaging | Coral Springs | Florida | Recruiting |
| Mayo Clinic Jacksonville | Jacksonville | Florida | Not Yet Recruiting |
| Moffit Cancer Center | Tampa | Florida | Recruiting |
| Robert H. Lurie Comprehensive Cancer Center of Northwestern University | Chicago | Illinois | Not Yet 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 | 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 |
More SOFIE trials in the USA
Other trials for the same condition
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 NCT07217704 on ClinicalTrials.gov ↗ ← All trials in the USA