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

Conditions

• Esophageal Cancer
• Gastric Cancer (GC)
• Gastroesophageal Junction

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• [18F]FAPI-74 PET/CT — DRUG
  \[18F\]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 Details

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.

Key Dates

Start date

Nov 14, 2025

Status verified

Jan 2026

Primary completion

Aug 30, 2027

Completion

Aug 30, 2027

Study Design

Enrollment

200 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Patients with gastric or esophageal cancer receiving [18F]FAPI-74

Primary Outcome Measure

Sensitivity and specificity for detection of distant metastatic disease (M1) using a composite SOT as reference [ Time Frame: From enrollment to the end of treatment after 3 month follow up ]

Central Contacts

• Alex Osipova
  1-800-753-5368
  [email protected]
• Bridget Adams
  1-800-753-5368
  [email protected]

Locations (14)

Find similar trials in Cerritos, CA

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