Pilot Study of Intravenous Anti-CD8 Minibody PET Imaging to Detect Immune Cells in the Central Nervous System of Adults With Multiple Sclerosis and Progressive Multifocal Leukoencephalopathy

What this Trial Is About

Researchers are studying multiple sclerosis MS, progressive multifocal leukoencephalopathy PML, and other neuroinflammatory diseases that affect the central nervous system CNS, including the brain, spinal cord, and optic nerves. These diseases can cause muscle weakness and problems with vision, speech, and coordination. The study aims to evaluate whether an experimental radioactive tracer called a minibody can help PET scans detect certain immune cells called CD8 plus T cells in the CNS of adults with these conditions. Participants will receive an intravenous injection of the minibody tracer during study visits. The study includes separate groups for MS, PML, and other neuroinflammatory diseases with a breakdown of up to four visits for MS and other diseases, and up to seven visits for PML. Visits involve MRI scans of the brain and spinal cord with contrast, PETCT scans on consecutive days, and optional additional PET scans. The PML group may have a repeat minibody injection and PET scan within six months to assess changes over time. During the study, participants will undergo physical and neurological exams, blood tests, heart function tests before and after minibody injection, and an MRI brain scan. Some may have a spinal tap to collect spinal fluid. PET scans will take about one hour, with participants lying on a table moving through a scanning machine. Researchers will measure how well the minibody identifies immune cells in different CNS tissues and monitor safety and tolerability. The study will last about 4 to 6 weeks, with some participants possibly followed for up to six months.

Central Nervous System Uptake of Anti-CD8+ T Cell Minibodies in Multiple Sclerosis and Progressive Multifocal Leukoencephalopathy