NCT02370563

PET Imaging of Intracranial Cancers With 18F-FSPG

An Open-Label Study of the Efficacy of 18F-FSPG PET/CT in Subjects With Intracranial Cancers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Life Molecular Imaging SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Brain Cancer

Interventions

Type	Name	Description
DRUG	18F-FSPG	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%).

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2015-02-25
• Last updated: 2016-09-02

Locations

1 site across 1 country: United States