PET monitoring for MS therapy
Research type
Research Study
Full title
Clinical evaluation of TSPO-targeting PET imaging to predict the efficacy of disease-modifying therapy in multiple sclerosis
IRAS ID
146504
Contact name
Richard Nicholas
Contact email
Sponsor organisation
Imperial College Healthcare NHS Trust
Research summary
Multiple Sclerosis (MS) affects over 100,000 individuals in the UK alone, and 2.5 million individuals worldwide. It is the commonest cause of disability in young adults.
In recent years, natalizumab (Tysabri) has emerged as an effective treatment for MS. However, there is marked variability in treatment response: some patients respond very well to natalizumab, while others continue to have disease relapses, loss of brain tissue, and associated progression of irreversible disability.
At present, it is not possible to predict, early on, which patients will respond to natalizumab, or indeed any other medication. This is a critical unmet need in multiple sclerosis, for several reasons: medication side effects can be severe, medications can be expensive and cumbersome to take, and, most importantly, any time spent receiving ineffective treatment is time lost in the fight against progressive loss of brain tissue and irreversible disability. If one could monitor disease activity, non-responders could have the ineffective therapy stopped, and could be switched to alternative highly-active therapy.
Microglia are a type of brain cell, which play a key role in MS. TSPO-PET is an imaging technique, that can produce images of microglia activity. TSPO-PET has already succeeded in showing increased microglia activity in people with MS. We believe TSPO-PET may be useful for the critical unmet need, as described above: to predict and monitor response to treatment.
In this study, we aim to recruit 25 people with MS, who are due to start natalizumab for clinical reasons. We shall perform a selection of investigations over a 13-month period, before and after they start the medication, including TSPO-PET scans, MRI scans, visual evoked potentials, and blood tests. The primary aim is to evaluate whether TSPO-PET scans can predict response to treatment, at an early time point. Healthy controls will also be recruited.
REC name
London - Riverside Research Ethics Committee
REC reference
14/LO/0343
Date of REC Opinion
17 Mar 2014
REC opinion
Favourable Opinion