Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Pancreatic Ductal Adenocarcinoma (PDAC)

Study acronym: FAPI-PRO
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 6 of 6 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: 4 to 6v5
  6. Study sites: 3 to 4v4
  7. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 3
    • Start date changed from estimate of Dec 23, 2025 to Dec 11, 2025
    v3
  8. Study sites: 0 to 1
    • Start date: Dec 15, 2025 to Dec 23, 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
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Pancreatic Cancer
1,740 trials monitored
See 105 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 pancreatic ductal adenocarcinoma. 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 NCT07217717
Lead Sponsor SOFIE
Conditions
(from sponsor)		 Pancreatic Ductal Adenocarcinoma (PDAC)
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov