Recruiting

Phase 3

[F18]FAPI-74Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.

Sponsor:

SOFIE

Code:

NCT07217704

Conditions

Esophageal Cancer

Gastric Cancer (GC)

Gastroesophageal Junction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[18F]FAPI-74 PET/CT

Study Details

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

Study ID

NCT07217704

Start date

Nov 14, 2025

Status verified date

Jan, 2026

Completion date

Aug 30, 2027

Anticipated

Primary completion date

Aug 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

Interventions

[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.

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 and Locations

Central contacts

Alex Osipova

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

Bridget Adams

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

Locations

Helios CR Inc./RadNet

Recruiting

Cerritos, California, United States, 90703

Contacts

Sabrina Mora

562-693-4477 Sabrina.mora@heliosclinical.com

Alexis Velasco

alexis.velasco@heliosclinical.com

Principal Investigator:

Omkar Marathe, M.D.

City of Hope National Cancer Center

Recruiting

Duarte, California, United States, 91010

Contacts

Miranda Qian

(626) 218-3533 lqian@coh.org

Principal Investigator:

Dani Castillo, M.D.

Hoag Memorial Hospital

Recruiting

Irvine, California, United States, 92618

Contacts

Beth Thomsen

949-557-0285 Beth.thomsen@hoag.org

Principal Investigator:

Gary Ulaner, MD

UCLA

Recruiting

Los Angeles, California, United States, 90095

Contacts

Steven Stokes

310 206-7436 SStokes@mednet.ucla.edu

Principal Investigator:

Mark Girgis, MD

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Kavin Tamizhmani

(650)-497-6046 ktamizhm@stanford.edu

Principal Investigator:

Matteo Novello, MD

Moffit Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Jacqueline Guillermo Adams

813-745-2468 Jacqueline.GuillermoAdams@moffitt.org

Principal Investigator:

Ghassan El-Haddad, MD

Indiana University Health University Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Eric Grubbs

(317) 274-2584 eegrubbs@iu.edu

Principal Investigator:

Cindy Yuan, MD PhD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Isabelle Lin

617-643-6837 ilin4@mgh.harvard.edu

Principal Investigator:

Shadi Esfahani, MD

UMass/Shields

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Sara Schiller

774-548-1090 Sara.Schiller1@umassmed.edu

Principal Investigator:

Elisa Franquet-Elia, MD

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Kera Delaney

507-293-2227 delaney.kera@mayo.edu

Principal Investigator:

Ajit H Goenka, MD

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Jordayna Francois

(646)888-6819 francoij@mskcc.org

Principal Investigator:

Aria Razmari, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44194

Contacts

Molly Haberkorn

216-445-6434 HABERKS@ccf.org

Principal Investigator:

Nicholas Austin, DO

Kettering

Recruiting

Kettering, Ohio, United States, 45429

Contacts

Kathren Garber

937-395-8390 kathren.garber@ketteringhealth.org

Principal Investigator:

Arif Sheikh, MD

University of Pennsylvania, Perelman School of Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Erin Schubert

215-573-6569 Erin.schubert@pennmedicine.upenn.edu

Principal Investigator:

Mark Sellmyer, MD, PhD

More Information

Sponsor

SOFIE

Last update posted

Jun 30, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by SOFIE on 2026-06-30.