A Phase 3 interventional study of [18F]FAPI-74 PET/CT in Esophageal Cancer, Gastric Cancer (GC) and Gastroesophageal Junction, sponsored by SOFIE. Recruiting at 16 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by SOFIE · Phase 3, Interventional, and Diagnostic
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.
1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.
This study's planned enrollment of 200 is above the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →SOFIE is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: [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.
Sensitivity and specificity for detection of distant metastatic disease (M1) using a composite SOT as reference
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
Time frame: From enrollment to the end of treatment after 3 month follow up
Incidence and severity of adverse events using CTCAE v5.
To assess the safety profile of \[¹⁸F\]FAPI-74.
Time frame: 24-72 hours post-injection
Sensitivity and specificity for the localized detection of peritoneal metastases
To evaluate the diagnostic performance of \[18F\]FAPI-74 PET/CT for detecting peritoneal metastatic disease
Time frame: From enrollment to the end of treatment after 3 month follow up
Comparative sensitivity and specificity between [18F]FAPI-74 and [¹⁸F]FDG PET/CT for detection of M1 disease using a composite SOT as reference
To compare clinical accuracy of \[18F\]FAPI-74 PET/CT imaging to that of \[¹⁸F\]FDG PET/CT, for participants who have had this performed, for detection of metastatic disease.
Time frame: From enrollment to the end of treatment after 3 month follow up
Cohen's kappa for pairwise evaluation of inter- and intra-reader agreement
To assess inter-and intra-reader variability in image interpretation of the presence of metastatic disease
Time frame: From enrollment to the end of treatment after 3 month follow up
Number of participants with treatment-related adverse events as assessed by body temperature changes
To assess the safety profile of \[¹⁸F\]FAPI-74
Time frame: 24-72 hours post-injection
Number of participants with treatment-related adverse events as assessed by blood pressure changes
To assess the safety profile of \[¹⁸F\]FAPI-74
Time frame: 24-72 hours post-injection
Number of participants with treatment-related adverse events as assessed by respiration rate
To assess the safety profile of \[¹⁸F\]FAPI-74
Time frame: Time Frame: 24-72 hours post-injection
Number of participants with treatment-related adverse events as assessed by pulse rate
To assess the safety profile of \[¹⁸F\]FAPI-74
Time frame: 24-72 hours post-injection
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
SOFIE