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
- Diseases
- Gastric and esophageal cancer
- 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
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Helios CR Inc./RadNet Coordinator of this site? Confirm its status | Cerritos | United States | Recruiting |
| Robert H. Lurie Comprehensive Cancer Center of Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Not yet recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Impression Imaging Coordinator of this site? Confirm its status | Coral Springs | United States | Recruiting |
| City of Hope National Cancer Center Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| Indiana University Health University Hospital Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Hoag Memorial Hospital Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| Mayo Clinic- Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Not yet recruiting |
| Kettering Coordinator of this site? Confirm its status | Kettering | United States | Recruiting |
| UCLA Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| University of Pennsylvania Perelman School of Medicine Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Stanford University Coordinator of this site? Confirm its status | Stanford | United States | Recruiting |
| Moffit Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| UMass/Shields Coordinator of this site? Confirm its status | Worcester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.