Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers

Study acronym: 18F-FAPI-74 GI
StatusCompleted
PhasePhase 2
SponsorSOFIE
Started

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Record History

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  1. Results posted: Oct 1, 2026
    • Interventions: [18F]FAPI-74 PET/CT (Drug) to [18F]FAPI-74 PET/CT (Drug)
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 3 of 3 entries
  2. Primary endpoints: 1 to 3
    • Enrollment target: 109 to 112
    • Secondary endpoints: 2 to 3
    v11
  3. Primary and study completion dates: Jul 1, 2025 to Jun 30, 2025v10
  4. Trial status: Active, Not Recruiting to Completed
    • Enrollment target: estimated 120 to confirmed 109
    • Primary and study completion dates changed from estimate of Jun 30, 2025 to Jul 1, 2025
    v9
  5. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Feb 28, 2025 to Jun 30, 2025
    • Study completion date: Mar 31, 2025 to Jun 30, 2025
    • Site details revised at 6 of 6 sites
    v8
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  1. Primary completion date: Jul 31, 2024 to Feb 28, 2025
    • Study sites: 5 to 6
    v7
  2. Study sites: 4 to 5v6
  3. Study sites: 3 to 4v5
  4. Study sites: 1 to 3v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 27, 2023 to Apr 28, 2023
    v3
  6. Start date: Feb 28, 2023 to Apr 27, 2023v2
  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
Colorectal Cancer
3,405 trials monitored
See 162 trials at risk
Pancreatic Cancer
1,740 trials monitored
See 105 trials at risk
Liver Cancer
1,602 trials monitored
See 70 trials at risk
and 2 more diseases
Prospective, multi-center, open label, non-randomized clinical trial to assess efficacy of \[18F\]FAPI-74 to detect FAP expressing cells in patients diagnosed with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer. The \[18F\]FAPI-74 PET scan will be acquired in patients with proven GI cancers after initial staging using institutional standard methods. The PET scan results will be compared to FAP immunohistochemistry (as the primary objective) and histopathology (as the secondary objective) of the biopsied or resected tissues.
Trial Details
NCT Number NCT05641896
Lead Sponsor SOFIE
Conditions
(from sponsor)		 Gastrointestinal Cancers, Cholangiocarcinoma, Gastric Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Hepatocellular Carcinoma
Related terms Carcinoma, Hepatocellular, Cholangiocarcinoma, Colorectal Neoplasms, Gastrointestinal Neoplasms, Stomach Neoplasms
Enrollment 112 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov