18F-Fluciclovine PET/CT for Brain Metastasis
This study is looking at how well a special scan, called an 18F-Fluciclovine (Axumin) PET/CT, can help doctors see and understand brain metastases (cancers that have spread to the brain). Researchers want to see how this scan picks up the cancer over time, both before and after treatment. They also hope it can help tell the difference between cancer growing back and other changes that can look similar on standard MRI scans. You might be able to join if you are an adult with suspected or diagnosed brain metastases, have a recent MRI showing the disease, and are scheduled for treatment like surgery or radiation. The goal is to see if this scan can provide clearer information for your doctors.
- Study design
- This is a single-arm study involving 20 participants. It is an interventional study, meaning participants will receive a diagnostic test.
- What's involved
- You will undergo an 18F-fluciclovine head PET/CT scan before your brain lesion treatment. You will also have a second 18F-fluciclovine PET/CT scan after treatment, around the same time as your post-procedure MRI.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will assess some aspects of the scan's use up to 3 years from the start of the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Feasibility of 18F-Fluciclovine PET/CT to Identify Brain Metastasis
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Bital Savir-Baruch, MD · PRINCIPAL_INVESTIGATOR · University of Arizona
Who to contact
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What this trial measures
- Characterization of the dynamics of 18F-fluciclovine uptake within a metastatic brain lesion over 60 mins.Baseline
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.
- Assessment of the dynamics of 18F-fluciclovine uptake within recently treated metastatic brain lesions.2 months from baseline
As a second phase of this study 20 patients who underwent baseline PET/CT will undergo a second 18F-fluciclovine PET/CT to evaluate 18F-fluciclovine uptake in treated lesions over 60 minutes. Uptake within the lesions and the benign brain parenchyma will be plotted on a 60 min time activity curve. Absolute SUV values will be compared with contralateral normal brain, cerebellum, pituitary gland, and superior sagittal sinus (SSS)\[1\]. We hypothesize that uptake of lesions with complete response will demonstrate significant reduction of uptake with persistent mild uptake above the pituitary gland. Focal uptake will be considered as residual viable disease. Truth will be corelated with histology confirmation, Standard of care (SOC) images, and or follow up.
- Evaluate the potential use of 18F-fluciclovine in delineating true local progression from radionecrosis in patients with clinical uncertainty of indeterminate MRI.3 years from baseline
For this Aim, 10 patients who underwent localized brain lesion/s management and are presenting with intermediate surveillance MRI results for true local recurrence or radionecrosis will undergo a 3rd 18F-fluciclovine PET/CT to evaluate the use of 18F-fluciclovine to delineate true progression from radionecrosis. The investigators will evaluate scan results, against positive histology confirmation or confirmatory follow up with standard of care images.