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18F-FAPI PET for Detecting Metastatic Gastric or Esophageal Cancer

This study is testing a new imaging method called [18F]FAPI-74 PET/CT to find out if cancer has spread (metastatic disease) in people with gastric (stomach), esophageal (food pipe), or gastroesophageal junction cancer. [18F]FAPI-74 is a special dye that helps doctors see cancer cells and related cells using a PET scan. The study wants to see how well this scan works compared to standard tests. You might be able to join if you are an adult (18 or older) with one of these cancers and are having tests to plan your treatment. The study aims to enroll 200 participants. The current recruitment status is unclear.

Study design
This is a multi-site, open-label study, meaning both you and the study team will know which treatment you are receiving. It is not randomized and involves a single dose of the imaging agent.
What's involved
After screening, you will receive a single dose of [18F]FAPI-74 and undergo a PET/CT scan. Standard care procedures will be monitored for about 3 months after the injection.
Compensation
Not stated in the trial record.
Follow-up
Your standard care procedures and interventions will be captured for 3 months +/-14 days after the injection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07217704

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

Recruiting
PHASE3Ages 18+InterventionalDiagnostic
SOFIE
~200 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:[18F]FAPI-74 PET/CT

At a glance

Recruiting sites
14 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity and specificity for detection of distant metastatic disease (M1) using a composite SOT as reference
Measured over From enrollment to the end of treatment after 3 month follow up

Conditions

Esophageal Cancer
Gastric Cancer (GC)
Gastroesophageal Junction

Explore related trials

Esophageal CarcinomaGastric CarcinomaGastroesophageal Junction Adenocarcinoma

Where it's being run

15 sites across 8 states
California5
Massachusetts2
New York2
Ohio2
Florida1
Indiana1
Minnesota1
Pennsylvania1

Study leadership

  • Sherly Mosessian, Ph.D · STUDY_DIRECTOR · SOFIE

Who to contact

Alex Osipova
[email protected]
1-800-753-5368
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Sensitivity and specificity for detection of distant metastatic disease (M1) using a composite SOT as referenceFrom enrollment to the end of treatment after 3 month follow up

    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