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Cutting Edge Imaging With PET-FAPI for Earlier Pancreatic Cancer Diagnosis (INDIGO-FAPI)

Study acronym: INDIGO-FAPI
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Minor Interventions: 68Ga-FAPI-46 for PET / CT scan and 177Lu-EB-FAPI for therapy (Drug) to 68Ga-FAPI-46 for PET / CT scan (Drug)
    • Study description revised
    • Eligibility criteria shortened, about 1 word
    v8
  2. Notable Primary completion date: Jan 30, 2029 to Aug 4, 2029
    • Start date: Oct 17, 2025 to Dec 2, 2025
    • Study completion date: Jan 30, 2030 to Aug 8, 2030
    v7
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 30, 2025 to Oct 17, 2025
    • Site details revised
    v6
  4. Minor Study title expanded, about 1 wordv5
  5. Minor Interventions: 68Ga-FAPI for PET / CT scan and 177Lu-EB-FAPI for therapy (Drug) to 68Ga-FAPI-46 for PET / CT scan and 177Lu-EB-FAPI for therapy (Drug)
    • Secondary endpoints: 1 to 2
    • Study description revised
    v4
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  1. Notable Start date: Jan 30, 2025 to Sep 30, 2025v3
  2. Minor Study sites: 0 to 1v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
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Assessment of the relevance of a new medical imaging test, FAPI PET, which could detect progression or relapse earlier than other tests currently available. Ultimately, it could enable early forms of pancreatic cancer to be detected and used for screening. In addition to the usual examinations prescribed, FAPI PET scans will be repeated at several points in the treatment process. All study patients must first have been included in the Homing cohort (NCT 04363983, APHP promotion). Clinical characteristics, judgement criteria and results of biological or imaging examinations carried out as part of this cohort will be shared. Patient follow-up and participation in the study ends when conventional imaging (CT and MRI) shows disease progression, relapse or death.
Trial Details
NCT Number NCT06659705
Lead Sponsor Institut Curie
Conditions
(from sponsor)
Pancreatic Ductal Adenocarcinoma (PDAC)
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov