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Esophageal CancerPhase 3FAPI-GONCT07217704

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

A Phase 3 study testing [18F]FAPI-74 PET/CT in people with Esophageal Cancer and Gastric Cancer (GC), run by SOFIE at 19 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
[18F]FAPI-74 PET/CT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
19 sitesUnited States
Study dates
14 Nov 2025to 30 Aug 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

19 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Alex Osipova contact

1-800-753-5368

Alex.osipova@sofie.com

Bridget Adams contact

1-800-753-5368

bridget.adams@sofie.com

19 sites in 1 country

United States19 sites, 19 recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Isabelle Lin, 617-643-6837, ilin4@mgh.harvard.edu

    Shadi Esfahani, MD

    Recruiting

  • Helios CR Inc./RadNet

    Cerritos, California, 90703

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

    Alexis Velasco, alexis.velasco@heliosclinical.com

    Recruiting

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago, Illinois, 60611

    Forest Hynes, 3126949930, forest.hynes@nm.org

    Ryan Avery, MD

    Not yet recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44194

    Molly Haberkorn, 216-445-6434, HABERKS@ccf.org

    Nicholas Austin, DO

    Recruiting

  • Impression Imaging

    Coral Springs, Florida, 33065

    Isaiah Brazle, 9543480103, ibrazle@impressionimaging.com

    Michael Fagien, MD

    Recruiting

  • City of Hope National Cancer Center

    Duarte, California, 91010

    Miranda Qian, (626) 218-3533, lqian@coh.org

    Dani Castillo, M.D.

    Recruiting

  • Indiana University Health University Hospital

    Indianapolis, Indiana, 46202

    Eric Grubbs, (317) 274-2584, eegrubbs@iu.edu

    Cindy Yuan, MD PhD

    Recruiting

  • Hoag Memorial Hospital

    Irvine, California, 92618

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

    Gary Ulaner, MD

    Recruiting

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

    Chyann Moore, 507-266-6759, Moore.chyann@mayo.edu

    Conor O'Donnell, MB, BCh, BAO

    Not yet recruiting

  • Kettering

    Kettering, Ohio, 45429

    Kathren Garber, 937-395-8390, kathren.garber@ketteringhealth.org

    Arif Sheikh, MD

    Recruiting

  • UCLA

    Los Angeles, California, 90095

    Steven Stokes, 310 206-7436, SStokes@mednet.ucla.edu

    Mark Girgis, MD

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Kyersten Hoene, 9209796340, khoene@mcw.edu

    Michael Holt, MD

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Ilda Bander, 212-241-0763, Ilda.bander@mountsinai.org

    Sampanna Rayamajhi, MD

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Jordayna Francois, (646)888-6819, francoij@mskcc.org

    Aria Razmari, MD

    Recruiting

  • University of Pennsylvania, Perelman School of Medicine

    Philadelphia, Pennsylvania, 19104

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

    Mark Sellmyer, MD, PhD

    Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

    Kera Delaney, 507-293-2227, delaney.kera@mayo.edu

    Ajit H Goenka, MD

    Recruiting

  • Stanford University

    Stanford, California, 94305

    Kavin Tamizhmani, (650)-497-6046, ktamizhm@stanford.edu

    Matteo Novello, MD

    Recruiting

  • Moffit Cancer Center

    Tampa, Florida, 33612

    Jacqueline Guillermo Adams, 813-745-2468, Jacqueline.GuillermoAdams@moffitt.org

    Ghassan El-Haddad, MD

    Recruiting

  • UMass/Shields

    Worcester, Massachusetts, 01655

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

    Elisa Franquet-Elia, MD

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
[18F]FAPI-74 PET/CT
Keywords
FAP, Fibroblast Activation Protein, Fibroblast Activation Protein Inhibitor, FAPI, gastroesophageal cancer, PET
Medical subject headings
Esophageal Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F]FAPI-74 PET/CTDrug

    [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 groups in NCT07217704
Study groupRoleWhat they receive
Patients with gastric or esophageal cancer receiving [18F]FAPI-74ExperimentalNot described
Receives: Drug: [18F]FAPI-74 PET/CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (8)

  1. Incidence and severity of adverse events using CTCAE v5.

    To assess the safety profile of [¹⁸F]FAPI-74.

    Measured: 24-72 hours post-injection

  2. Sensitivity and specificity for the localized detection of peritoneal metastases

    To evaluate the diagnostic performance of [18F]FAPI-74 PET/CT for detecting peritoneal metastatic disease

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

  3. Comparative sensitivity and specificity between [18F]FAPI-74 and [¹⁸F]FDG PET/CT for detection of M1 disease using a composite SOT as reference

    To compare clinical accuracy of [18F]FAPI-74 PET/CT imaging to that of [¹⁸F]FDG PET/CT, for participants who have had this performed, for detection of metastatic disease.

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

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

    To assess inter-and intra-reader variability in image interpretation of the presence of metastatic disease

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

  5. Number of participants with treatment-related adverse events as assessed by body temperature changes

    To assess the safety profile of [¹⁸F]FAPI-74

    Measured: 24-72 hours post-injection

  6. Number of participants with treatment-related adverse events as assessed by blood pressure changes

    To assess the safety profile of [¹⁸F]FAPI-74

    Measured: 24-72 hours post-injection

  7. Number of participants with treatment-related adverse events as assessed by respiration rate

    To assess the safety profile of [¹⁸F]FAPI-74

    Measured: Time Frame: 24-72 hours post-injection

  8. Number of participants with treatment-related adverse events as assessed by pulse rate

    To assess the safety profile of [¹⁸F]FAPI-74

    Measured: 24-72 hours post-injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2025
  2. Study start14 Nov 2025
  3. Primary completion30 Aug 2027 (estimated)
  4. Study completion30 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07217704
Sponsor's protocol ID
18FFAPI-2025P3-GEC
Acronym
FAPI-GO
Status last verified
Jan 2026
First submitted
14 Oct 2025
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing [18F]FAPI-74 PET/CT in people with Esophageal Cancer and Gastric Cancer (GC), run by SOFIE at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alex Osipova (1-800-753-5368, Alex.osipova@sofie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07217704.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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