OncoMatch/Clinical Trials/NCT06055790
Feasibility of 18F-Fluciclovine PET/CT to Identify Brain Metastasis
Is NCT06055790 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for brain metastases.
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.
Check if I qualifyExtracted eligibility criteria
Disease stage
Metastatic disease required
Prior therapy
Cannot have received: brain biopsy
Exception: allowed if >4 weeks from PET/CT
Patients who have had a brain biopsy of the index lesion(s) sooner than 4 weeks from the brain 18F-fluciclovine PET/CT
Cannot have received: brain surgery
Exception: allowed if at least one index lesion is not adjacent to previous treatment (10% isodose line of prior RT)
Patients who have had prior brain surgery or radiation treatment of the index lesion(s). Prior history of localized brain treatment (surgery or stereotactic radiosurgery /fractionated stereotactic radiotherapy) allowed, if at least one index lesion is not adjacent to previous treatment (10% isodose line of prior RT).
Cannot have received: radiation therapy
Exception: allowed if at least one index lesion is not adjacent to previous treatment (10% isodose line of prior RT)
Patients who have had prior brain surgery or radiation treatment of the index lesion(s). Prior history of localized brain treatment (surgery or stereotactic radiosurgery /fractionated stereotactic radiotherapy) allowed, if at least one index lesion is not adjacent to previous treatment (10% isodose line of prior RT).
Cannot have received: systemic therapy
Patients who have had treatment of the index brain lesion(s) or initiation of systemic therapy after the last MRI and prior to the PET/CT scan
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Arizona Cancer Center at UMC North/University Medical Center · Tucson, Arizona
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