18F-FAPI PET/CT to find spread of stomach 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
We will test whether a single [18F]FAPI-74 PET/CT scan can find metastatic disease in adults with confirmed gastric, gastroesophageal junction, or esophageal cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sofie Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 10 sites (Cerritos, California and 9 other locations) |
| Trial ID | NCT07217704 on ClinicalTrials.gov |
What this trial studies
This multi-site, open-label, non-randomized Phase 3 imaging protocol administers a single dose of [18F]FAPI-74 followed by PET/CT using a standardized procedure. Adults with pathologically confirmed gastric, gastroesophageal junction, or esophageal cancer undergo the PET/CT and their standard-of-care procedures are captured for about three months to compare imaging findings. The primary outcome is the sensitivity and specificity of [18F]FAPI-74 PET/CT for detecting metastatic disease using a composite standard-of-truth panel. Safety follow-up occurs for 24 to 72 hours after the scan and the program is expected to run about 24 months from first patient screening to last SOC follow-up.
Who should consider this trial
Good fit: Adults (≥18) with pathologically confirmed gastric, gastroesophageal junction, or esophageal cancer who are undergoing staging, have ECOG ≤2, can give informed consent, and can complete a contrast-enhanced CT within 21 days are ideal candidates.
Not a fit: Patients who already have clear, documented metastatic disease at enrollment or who cannot undergo PET/CT or the required contrast-enhanced CT are unlikely to gain diagnostic benefit from this scan.
Why it matters
Potential benefit: If successful, this scan could help find hidden metastases earlier and improve staging and treatment planning.
How similar studies have performed: Early single-center and pilot studies of FAPI PET have shown promising lesion detection across several cancers including gastroesophageal tumors, but large multicenter Phase 3 evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cerritos, California and 9 other locations
- Helios CR Inc./RadNet — Cerritos, California, United States (Recruiting)
- Hoag Memorial Hospital — Irvine, California, United States (Recruiting)
- UCLA — Los Angeles, California, United States (Recruiting)
- Moffit Cancer Center — Tampa, Florida, United States (Recruiting)
- Indiana University Health University Hospital — Indianapolis, Indiana, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- UMass/Shields — Worcester, Massachusetts, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- Kettering — Kettering, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Alex Osipova
- Email: Alex.osipova@sofie.com
- Phone: 1-800-753-5368
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.