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Initial Staging of Lobular Breast Carcinoma: Head to Head Comparison of 68Ga-FAPI-46 and 18F-FDG PET/CT

Study acronym: GALILEE
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. 3 versions Re-verified since Apr 10, 2026, no change to tracked fieldsv12-v14
  2. Secondary endpoints: 8 to 9v11
  3. Re-verified, no change to tracked fieldsv10
  4. Site details revisedv9
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Re-verified, no change to tracked fieldsv7
  2. Primary and study completion dates: Apr 2026 to Nov 2026v6
  3. 2 versions Re-verified since Mar 29, 2024, no change to tracked fieldsv4-v5
  4. Start date changed from estimate of Oct 16, 2023 to Nov 16, 2023v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Aug 2023 to Oct 16, 2023
    • Primary and study completion dates: Feb 2026 to Apr 2026
    • Site details revised
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Lobular Breast cancer staging with 18F-fluorodeoxyglucose positron emission tomography (18F-FDG PET) is not optimal due to the poor accumulation of 18F-FDG in the tumour. Through better sensitivity (and specificity), 68Ga-FAPI-46-46 PET should provide a more accurate staging of lobular breast cancer than 18F-FDG PET.
Trial Details
NCT Number NCT05931302
Lead Sponsor Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborators: Institut Curie, Centre Antoine Lacassagne
Conditions
(from sponsor)		 Lobular Breast Carcinoma
Related terms Carcinoma, Lobular
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov