PET Imaging of Intracranial Cancers With 18F-FSPG
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|ClinicalTrials.gov Identifier: NCT02370563|
Recruitment Status : Terminated (Business decision)
First Posted : February 25, 2015
Last Update Posted : September 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Brain Cancer||Drug: 18F-FSPG||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Study of the Efficacy of 18F-FSPG PET/CT in Subjects With Intracranial Cancers|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Experimental: Arm 1
18F-FSPG will be administered to 30 patients with brain tumors or brain metastases.
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%).
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370563
|United States, California|
|Stanford University Medical Center|
|Stanford, California, United States, 94305|
|Study Director:||Norman Koglin, PhD||Life Molecular Imaging SA|