RecruitingPhase 3NCT07217704

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

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

Sponsor

SOFIE

Enrollment

200 participants

Start Date

Nov 14, 2025

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer Gastric Cancer (GC)Gastroesophageal Junction

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a special type of PET scan (a whole-body imaging test) with a tracer called 18F-FAPI to check whether it can better detect the spread of stomach or esophageal cancer compared to standard CT scans. Better imaging can help doctors plan more accurate treatment. **You may be eligible if...** - You are 18 or older and have been diagnosed with stomach cancer, esophageal cancer, or cancer at the junction of the stomach and esophagus - You are undergoing evaluation to plan your treatment (staging) - You are generally well enough to complete the imaging and procedures - You have had or are planned for a standard CT scan of the chest, abdomen, and pelvis **You may NOT be eligible if...** - You already have clear evidence that cancer has spread to other organs in a way that rules out surgery - You have a known allergy to the imaging tracer used in the study - You have participated in another experimental study in the past 30 days - You are pregnant or of childbearing potential and not using effective contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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.