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Feasibility of 18F-Fluciclovine PET/CT to Identify Brain Metastasis

StatusRecruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Notable Phase changed: Phase 2 → Early Phase 1 Show 4 more changesShow less
    • Interventions: 18F-Fluciclovine (Axumin) PET/CT (Diagnostic Test) to 18F-Fluciclovine (Axumin) PET/CT (Diagnostic Test)
    • Eligibility criteria expanded, about 15 words
    • Site details revised
    • Publications: details revised at 1 of 1 entry
  2. Minor Re-verified, no change to tracked fieldsv7
  3. Minor Start date changed from estimate of Aug 2024 to Sep 10, 2024v6
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jul 1, 2024 to Aug 2024
    • Site details revised
    v5
  5. Notable Start date: Apr 1, 2024 to Jul 1, 2024v4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Start date: Oct 31, 2023 to Apr 1, 2024v3
  2. Minor Interventions: 18F-Fluciclovine PET/CT (Diagnostic Test) to 18F-Fluciclovine (Axumin) PET/CT (Diagnostic Test)
    • Study description expanded, about 2 words
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this diagnostic intervention clinical trial is to compare 18F-Fluciclovine uptake within brain lesions over 60 minutes compared with standard of care positive histology confirmation or confirmation MRI images. The main questions it aims to answer are: 1. What are the dynamics of 18F-Fluciclovine update within a non-treated metastatic brain lesion over 60 minutes? 2. What are the dynamics of 18F-fluciclovine update within recently treated metastatic brain lesions? 3. What is the potential use of 18F-Fluciclovine in delineating true local progression from radionecrosis in patients with clinical uncertainty of indeterminate MRI? Participants will undergo an 18F-fluciclovine head PET/CT scan prior to treatment for brain metastatic lesion(s). The study will characterize uptake dynamic PET images over 60 minutes. Uptake within the lesions and the benign brain parenchyma will be plotted on a time activity curve for 60 mins. Patients will undergo a second 18F-fluciclovine PET/CT to evaluate 18F-fluciclovine uptake in treated lesions over 60 minutes. This will be offered concurrently with the post-procedure standard of care (SOC) MRI to evaluate post-treatment changes. Uptake within the lesions and the benign brain parenchyma will be plotted on a 60 min time activity curve. Results will be compared to the pre-treatment baseline images. A third 18F-fluciclovine PET/CT will be offered to evaluate post radiation changes necrosis from recurrence, for up to 10 patients in our cohort who are under clinical surveillance (up to three years surveillance) and developed MRI evidence of either true progression or radionecrosis with clinical uncertainty after stereotactic radiosurgery. The initial 18F-fluciclovine PET/CT will serve as a baseline PET/CT scan. This will be compared to post procedural histological confirmation.
Trial Details
NCT Number NCT06055790
Lead Sponsor University of Arizona
Collaborators: Blue Earth Diagnostics
Conditions
(from sponsor)
Brain Metastases
Related terms Brain Neoplasms
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov