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

NCT07217704 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 18FFAPI-2025P3-GEC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Esophageal Cancer; Gastric Cancer (GC); Gastroesophageal Junction

Keywords

FAP; Fibroblast Activation Protein; Fibroblast Activation Protein Inhibitor; FAPI; gastroesophageal cancer; PET

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment to the end of treatment after 3 month follow up

Secondary Outcomes (8)

• Incidence and severity of adverse events using CTCAE v5.

  24-72 hours post-injection

• Sensitivity and specificity for the localized detection of peritoneal metastases

  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

  From enrollment to the end of treatment after 3 month follow up

• Cohen's kappa for pairwise evaluation of inter- and intra-reader agreement

  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

  24-72 hours post-injection

Study Arms (1)

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

EXPERIMENTAL

Drug: [18F]FAPI-74 PET/CT

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adults ≥ 18 years.
• Participants with confirmed gastric, esophageal or gastroesophageal malignancy undergoing staging evaluation for treatment planning.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
• Provided signed, written informed consent prior to any study-related procedures.
• Participants are required to have a ceCT scan of chest, abdomen and pelvis as per standard clinical practice and practice guidelines either 21 days or less prior to entry or planned within 21 days of \[¹⁸F\]FAPI-74 administration.
• For women who are not postmenopausal (two years of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use medically accepted, highly effective methods of contraception (e.g., hormonal implants, combined oral contraceptives, vasectomized partner, during the trial intervention period.

You may not qualify if:

• Unequivocal evidence of metastases at the time of enrollment that would preclude surgery as a treatment option.
• Known hypersensitivity to \[¹⁸F\]FAPI-74.
• Administration of another investigational diagnostic or therapeutic product within 30 days prior to \[¹⁸F\]FAPI-74 administration.
• Prior administration of a radiopharmaceutical within 10 half-lives of that product from the time of \[¹⁸F\]FAPI-74 administration.
• Previous cancer (except basal cell carcinoma of the skin or in situ carcinoma of the cervix/uterus (participants treated with curative intent and disease free for more than 5 years are permitted).
• Hepatic function: T. bili \>1.5X ULN or alk phos, ALT, or AST \>5X ULN
• Renal function: GFR \< 30 mL/min
• Pregnant or currently breast feeding (a negative pregnancy test is required in women of childbearing potential).
• Inability to undergo the PET/CT scanning procedure.
• Inflammatory bowel disease (Crohn's disease, ulcerative colitis)
• Sarcoidosis
• Treatment, including chemotherapy, radiation, immunotherapy or surgery for curative intent of Gastroesophageal cancers

Sponsors & Collaborators

• SOFIE: lead

Study Sites (10)

Helios CR Inc./RadNet

Cerritos, California, 90703, United States

RECRUITING

Hoag Memorial Hospital

Irvine, California, 92618, United States

RECRUITING

UCLA

Los Angeles, California, 90095, United States

NOT YET RECRUITING

Moffit Cancer Center

Tampa, Florida, 33612, United States

NOT YET RECRUITING

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

UMass/Shields

Worcester, Massachusetts, 01655, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44194, United States

NOT YET RECRUITING

Kettering

Kettering, Ohio, 45429, United States

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Sherly Mosessian, Ph.D

  SOFIE

  STUDY DIRECTOR

Central Study Contacts

Alex Osipova

CONTACT

1-800-753-5368; Alex.osipova@sofie.com

Bridget Adams

CONTACT

1-800-753-5368; bridget.adams@sofie.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2025
• First Posted: October 16, 2025
• Study Start: November 14, 2025
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)