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RECRUITING
NCT07217704
PHASE3

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

Sponsor: SOFIE

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-11-14

Completion Date

2027-08-30

Last Updated

2026-03-16

Healthy Volunteers

No

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.

Locations (10)

Helios CR Inc./RadNet

Cerritos, California, United States

Hoag Memorial Hospital

Irvine, California, United States

UCLA

Los Angeles, California, United States

Moffit Cancer Center

Tampa, Florida, United States

Indiana University Health University Hospital

Indianapolis, Indiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

UMass/Shields

Worcester, Massachusetts, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Kettering

Kettering, Ohio, United States