Feasibility of 18F-Fluciclovine PET/CT to Identify Brain Metastasis
ConditionBrain Metastases
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Arizona
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with clinically suspected or diagnosed brain metastatic lesion(s)
Age ≥ 18 years
Known history cancer
Brain MRI in the past 2 months positive for metastatic disease
Disqualifiers
Patients who do not meeting inclusion criteria.
Patients who have had a brain biopsy of the index lesion(s) sooner than 4 weeks from the brain 18F-fluciclovine PET/CT (to minimize false positive uptake due to inflammation).
Patients who have had prior brain surgery or radiation treatment of the index lesion(s).
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.
Trial design
Design model
Single group
Treatments tested in this trial
18F-Fluciclovine (Axumin) PET/CT
Diagnostic testPET/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. \[24, 27\].
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: 18F-Fluciclovine (Axumin) PET/CTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Characterization of the dynamics of 18F-fluciclovine uptake within a metastatic brain lesion over 60 mins.
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.
Time frame
Baseline2
Assessment of the dynamics of 18F-fluciclovine uptake within recently treated metastatic brain lesions.
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.
Time frame
2 months from baseline3
Evaluate the potential use of 18F-fluciclovine in delineating true local progression from radionecrosis in patients with clinical uncertainty of indeterminate MRI.
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.
Time frame
3 years from baselineSponsors and contacts
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University of Arizona
Lead sponsor
Blue Earth Diagnostics
Collaborator
Source ClinicalTrials.gov