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Construction and Clinical Translation of ACE Targeted Nuclear Medicine Imaging Probe

StatusCompleted
PhasePhase 1
Started
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Record History

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  1. Lead sponsor: Peking University Cancer Hospital & Institute to Peking University Cancer Hospital & Institute Show 6 more changesShow less
    • Trial completed
    • Final enrollment: 18 participants (planned 20)
    • Primary completion date changed from estimate of Dec 2, 2026 to Dec 18, 2025
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised
  2. Re-verified, no change to tracked fieldsv5
  3. Primary endpoint(s) modifiedv4 Show 7 more changesShow less
    • Phase changed: not specified → Phase 1
    • Start date: Jan 2, 2024 to Mar 6, 2024
    • Trial arms changed: 2 → 1
    • Interventions: 18F-FDG (Drug), 68Ga-DOTA-BPP (Drug)
    • Eligibility criteria expanded, about 369 words
    • Secondary endpoints: 1 to 2
    • Study description expanded, about 35 words
  4. Primary and study completion dates: Oct 2024 to Dec 2, 2026
    • Start date: Oct 1, 2022 to Jan 2, 2024
    • Primary endpoints: 2 to 1
    • Secondary endpoints: 2 to 1
    v3
  5. Re-verified, no change to tracked fieldsv2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This prospective, single-center, open-label study aims to evaluate the safety, biodistribution, and tumor imaging characteristics of the novel ACE1-targeted PET radiotracer 68Ga-DOTA-BPP in patients with confirmed or suspected triple-negative breast cancer (TNBC). Participants will undergo \^68Ga-DOTA-BPP PET/CT and 18F-FDG PET/CT. Visual and semiquantitative imaging analyses will be performed to assess tracer uptake in tumor lesions and normal organs. The relationship between \^68Ga-DOTA-BPP uptake and ACE1 expression will also be explored in participants with available tumor tissue.
Trial Details
NCT Number NCT06203119
Lead Sponsor Peking University Cancer Hospital & Institute
Conditions
(from sponsor)		 Cancer
Related terms Disease, Neoplasms
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov