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NCT07217704RecruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 19 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
200 (estimated)
First submitted
14 Oct 2025
Start date
14 Nov 2025
Primary completion date
30 Aug 2027
Lead sponsor
SOFIE
NCT number
NCT07217704

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 200
  • From 14 Nov 2025 to the primary completion date, 30 Aug 2027
  • 19 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Unequivocal evidence of metastases at the time of enrollment that would preclude surgery as a treatment option.
  • 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.

Other illness

  • Known hypersensitivity to \[¹⁸F\]FAPI-74.
  • 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).
  • Inflammatory bowel disease (Crohn's disease, ulcerative colitis)
  • Treatment, including chemotherapy, radiation, immunotherapy or surgery for curative intent of Gastroesophageal cancers

Lab values

  • Hepatic function: T. bili \>1.5X ULN or alk phos, ALT, or AST \>5X ULN
  • Renal function: GFR \< 30 mL/min

Other

  • Pregnant or currently breast feeding (a negative pregnancy test is required in women of childbearing potential).
  • Inability to undergo the PET/CT scanning procedure.
  • Sarcoidosis

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (19)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Massachusetts General Hospital
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BostonUnited StatesRecruiting
Helios CR Inc./RadNet
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CerritosUnited StatesRecruiting
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
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ChicagoUnited StatesNot yet recruiting
Cleveland Clinic
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ClevelandUnited StatesRecruiting
Impression Imaging
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Coral SpringsUnited StatesRecruiting
City of Hope National Cancer Center
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DuarteUnited StatesRecruiting
Indiana University Health University Hospital
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IndianapolisUnited StatesRecruiting
Hoag Memorial Hospital
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IrvineUnited StatesRecruiting
Mayo Clinic- Jacksonville
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JacksonvilleUnited StatesNot yet recruiting
Kettering
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KetteringUnited StatesRecruiting
UCLA
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Los AngelesUnited StatesRecruiting
Medical College of Wisconsin
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MilwaukeeUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesRecruiting
Icahn School of Medicine at Mount Sinai
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New YorkUnited StatesRecruiting
University of Pennsylvania Perelman School of Medicine
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PhiladelphiaUnited StatesRecruiting
Mayo Clinic - Rochester
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RochesterUnited StatesRecruiting
Stanford University
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StanfordUnited StatesRecruiting
Moffit Cancer Center
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TampaUnited StatesRecruiting
UMass/Shields
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WorcesterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.