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18F FES-PET/MRI for Tailoring Treatment of Luminal A and Lobular Breast Cancer

Study acronym: FESTA
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Phase: Not applicable to Phase 2v5 Show 11 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Enrollment target: 221 to 119
    • Primary completion date: May 15, 2027 to Jun 15, 2029
    • Start date changed from estimate of Mar 1, 2025 to Jun 9, 2026
    • Study sites: 0 to 1
    • Study completion date: Nov 1, 2028 to Dec 1, 2029
    • Interventions: FES (Drug), PET/MRI A (Procedure), PET/MRI B (Procedure), PET/MRI C (Procedure), PET/MRI D (Procedure), Translational analysis (Genetic) to FES (Drug), PET/MRI A (Procedure), Translational analysis (Genetic)
    • Eligibility criteria shortened, about 31 words
    • Secondary endpoints shortened, about 15 words
    • Study description shortened, about 98 words
    • Study arms: 4 to 1
  2. Start date: Oct 15, 2024 to Mar 1, 2025
    • Collaborators: 2 to 1
    v4
  3. Start date: Oct 15, 2023 to Oct 15, 2024v3
  4. Lead sponsor: IRCCS San Raffaele to Università Vita-Salute San Raffaele
    • Collaborators: 1 to 2
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Study hypothesis is that combining the advantages of hybrid PET/MRI and the high sensitivity/specificity of 16-alpha-18F-fluoro-17-beta-estradiol(FES), a radiolabeled form of estrogen binding to functionally active ER, the investigators could obtain a reliable, non-invasive, operator-independent, one-stage imaging method for staging LumA and ER-positive Lobular tumours.
Trial Details
NCT Number NCT05982496
Lead Sponsor Università Vita-Salute San Raffaele
Collaborators: IRCCS San Raffaele
Conditions
(from sponsor)		 Breast Cancer Female, Lobular Breast Carcinoma, PET/MRI, Axillary Lymphadenopathy, Luminal A Breast Cancer
Related terms Carcinoma, Lobular
Enrollment 119 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov