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New scan aims to spot hidden cancer spread in stomach and esophageal tumors

NCT ID NCT07217704

Diagnosis Sponsor: SOFIE Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 6 times

Summary

This study is testing a new type of PET/CT scan called [¹⁸F]FAPI-74 to see if it can better detect when stomach or esophageal cancer has spread to other parts of the body. About 200 adults with these cancers will receive one dose of the scan tracer and be followed for up to 3 months. The goal is to see if this scan is more accurate than current methods for finding distant metastases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

esophageal cancer Esophageal Neoplasms gastric cancer gastric neoplasm gastroesophageal junction adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Esophageal cancer Gastric cancer (GC) Gastroesophageal junction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • City of Hope National Cancer Center

    RECRUITING

    Duarte, California, 91010, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44194, United States

  • Helios CR Inc./RadNet

    RECRUITING

    Cerritos, California, 90703, United States

  • Hoag Memorial Hospital

    RECRUITING

    Irvine, California, 92618, United States

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Indiana University Health University Hospital

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Kettering

    RECRUITING

    Kettering, Ohio, 45429, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Moffit Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Stanford University

    RECRUITING

    Stanford, California, 94305, United States

  • UCLA

    RECRUITING

    Los Angeles, California, 90095, United States

  • UMass/Shields

    RECRUITING

    Worcester, Massachusetts, 01655, United States

  • University of Pennsylvania, Perelman School of Medicine

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

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