The aim of this study is to explore the efficacy of 18F-FSPG in the detection of primary or metastatic brain cancer lesions confirmed by a standard of truth, preferably histology. This is a single center, open labelled, non-randomized study. A total of 30 subjects with brain tumor or brain metastases will be enrolled. All different stages of malignancies will be recruited, including those with different types of pathologies and grades, and newly diagnosed or recurrent disease.
Subjects with various types and grades of primary brain tumors or brain metastasis will be recruited. The brain tumor needs to be either histologically or clinically confirmed. 18F-FSPG will be injected intravenously into the subjects, and PET/CT imaging performed. Images will be assessed visually and quantitatively. Available tumor specimens will be analyzed by immunohistochemistry (IHC) for example for expression of components of the system xc- and associated biomarkers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
26
18F-FSPG is a novel F18-labelled, radiopharmaceutical agent for PET imaging. It is administered intravenously at a dose of 300 MBq (8.1mCi ± 10%).
Stanford University Medical Center
Stanford, California, United States
Location and number of lesions and their location as detected by 18F-FSPG uptake above background in the brain of each study subject following visual inspection of the 18F-FSPG PET/CT scans
Time frame: 0-75 min
Location and number of lesions detected in the whole body following visual inspection of the 18F-FSPG PET/CT scans
Time frame: 0-75 min
Location and number of lesions detected in the brain and whole body following visual inspection of the CT, MR or other available PET (e.g. 18F-FDG, 18F-FLT, etc.).
Time frame: <4 weeks from FSPG PET/CT scan
Lesion size measured by means of ROIs drawn on (contrast-enhanced) MR or CT.
Time frame: <4 weeks from FSPG PET/CT scan
18F-FSPG standardized uptake value (SUV) measured in each detected lesion and in the background (region without lesion).
Time frame: 0-75 min
SUV measured in each detected lesion and in the background using other available PET tracers (e.g. 18F-FDG, 18F-FLT, etc.).
Time frame: < 4 weeks from FSPG PET/CT scan
Determination of FSPG PET/CT image quality based on visual inspection.
Time frame: 0-75 min
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