NCT06055790

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-arm, 20 subject, pilot clinical trial utilizing 18F-fluciclovine PET/CT scan prior to treatment for brain metastatic lesion(s). Patients with recently diagnosed brain metastatic lesion(s) will be recruited based on MRI with or without histological confirmation, per standard of care. All patients will undergo an 18F-fluciclovine head PET/CT scan. 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. The investigators hypothesize that uptake will be above benign brain parenchyma. The 18F-fluciclovine PET/CT will serve as a baseline PET/CT scan. Subjects 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 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. Absolute SUV values of the lesions will be compared with contralateral normal brain, cerebellum, pituitary gland, and superior sagittal sinus. The investigators 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. The truth will be correlated with histology confirmation, SOC images, or follow up. 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 investigators hypothesize that the absolute uptake of lesions with radionecrosis will be significantly lower than that of true progression. The initial 18F-fluciclovine PET/CT will serve as a baseline PET/CT scan. This will be compared to post procedural histological confirmation. If study results are promising, a larger prospective cohort study will be designed.

Conditions

• Brain Metastases

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	18F-Fluciclovine (Axumin) PET/CT	PET/CT protocol: All patients will be instructed to fast for 4 hr. prior to the scan. CT imaging of the head will be performed using GE Discovery MI Digital PET/CT (Boston, Massachusetts) prior to the injection of 18F-fluciclovine. While the patient is in a supine position on the PET table, 5 mCi (185 MBq) of 18F-fluciclovine will be administrated intravenously, followed by a saline flush. At the time of the injection, a continuous dynamic PET images lasting 60 min will be performed using 3D-dynamic and list-mode acquisition: 2.0 mm slice thickness, number of frames(f) x time in seconds(s) and minutes(m) of: 4f x 15s, 4f x 30s, 6f x 2m, 5f x 3m, and 6f x 5m. PET images at 0-5 (flow), 15-25 (early), 25-35 (mid), 45-60 min (delayed) post-injection will be reconstructed using Qclear 500 and OSEM iterative reconstruction with TOF (VPFX): 8 iterations, 5 subsets, 440 image matrix, 4 mm Gaussian filter, TOF. \[24, 27\].

Timeline

• Start date: 2024-09-10
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2023-09-28
• Last updated: 2025-09-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study