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

Study acronym: FAPI-GO
StatusRecruiting
PhasePhase 3
SponsorSOFIE
Started

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Record History

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  1. Trial sites expanded: 16 → 19 locations
  2. Site details revised at 1 of 16 sites
  3. Study sites: 15 to 16
    • Interventions: [18F]FAPI-74 PET/CT (Drug) to [18F]FAPI-74 PET/CT (Drug)
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 8 of 8 entries
  4. Study sites: 14 to 15v11
  5. Trial sites expanded: 10 → 14 locationsv10
Show 8 earlier versionsHide 8 earlier versions
  1. Site details revised at 3 of 10 sitesv9
  2. Study sites: 8 to 10v8
  3. Study sites: 6 to 8v7
  4. Site details revised at 1 of 6 sitesv6
  5. Study sites: 5 to 6v5
  6. Study sites: 3 to 5v4
  7. Study sites: 1 to 3v3
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date: Nov 12, 2025 to Nov 14, 2025
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
SOFIE
4 trials monitored
See all monitored trials
Gastric Cancer
1,281 trials monitored
See 61 trials at risk
Esophageal Cancer
1,051 trials monitored
See 53 trials at risk
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.
Trial Details
NCT Number NCT07217704
Lead Sponsor SOFIE
Conditions
(from sponsor)		 Esophageal Cancer, Gastric Cancer (GC), Gastroesophageal Junction
Related terms Esophageal Neoplasms, Stomach Neoplasms
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov