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NCT06055790 · ClinicalTrials.gov registry record · Phase 2
Feasibility of 18F-Fluciclovine PET/CT to Identify Brain Metastasis
A Phase 2 study of Brain Metastases, sponsored by University of Arizona.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06055790: Recruiting Phase 2 study of Brain Metastases, sponsored by University of Arizona.
NCT06055790 is a Phase 2 study of Brain Metastases that is actively recruiting participants, run by University of Arizona. The registered enrollment target is 20 participants, below the 213-participant average among 67 other Brain Metastases trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06055790, a Phase 2 study of Brain Metastases, is actively recruiting participants, sponsored by University of Arizona.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
The primary objective is to evaluate whether anti-3-\[18F\]FACBC (FACBC, fluciclovine, Axumin) uptake (measured by standardized uptake values, SUV, and visualized uptake) in brain metastatic lesions is above normal brain background. We will evaluate scan results, against positive histology confirmation or confirmatory MRI images.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST 18F-Fluciclovine (Axumin) PET/CT
Study Locations (1)
Arizona
- Arizona Cancer Center at UMC North/University Medical Center - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-09-10 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 2 |
What NCT06055790 shows while recruiting
NCT06055790 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 213-participant average among 67 other Brain Metastases trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Brain Metastases appearing as the primary indexed condition, and to 1 intervention - of which 18F-Fluciclovine (Axumin) PET/CT is the first listed.
NCT06055790 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT06055790 about?
NCT06055790 is a clinical study titled "Feasibility of 18F-Fluciclovine PET/CT to Identify Brain Metastasis". 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-Flu...
What is the current status of trial NCT06055790?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2024-09-10. Estimated completion is 2026-10-31.
What conditions does trial NCT06055790 study?
This clinical trial studies the following conditions: Brain Metastases.
What interventions are being tested in trial NCT06055790?
The interventions under investigation include: 18F-Fluciclovine (Axumin) PET/CT (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06055790?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06055790 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06055790's enrollment target sits among peer trials
20 51st of 67 higher than 9 of 67 other Brain Metastases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Brain Metastases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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