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ISRCTN
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ISRCTN37780318
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ClinicalTrials.gov identifier
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Public title
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A spectral analysis of human brain tissue
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Scientific title
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A spectral analysis of human brain tissue: A single centre non-randomised intra-operative imaging trial
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Acronym
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N/A
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Serial number at source
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7568
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Study hypothesis
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When performing surgery it is essential to identify normal and abnormal brain to guide where surgery should be performed. Computed tomography (CT) and magnetic resonance imaging (MRI) guided surgery is expensive and can have its limitations. It has been hypothesised however that the light reflected from the human brain is subtly different between normal and abnormal tissue. This is so subtle that as to not be apparent to the naked eye but may be detectable if the light is split into its individual wavelengths' and analysed by a very sensitive camera. If these differences are detectable then this could form the basis of new ways of making surgery safer.
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Ethics approval
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Southampton and Southwest Hampshire Research Ethics Committee approved on the 22nd February 2007 (ref: 06/Q1704/139)
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Study design
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Single centre non-randomised interventional diagnosis and screening trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Topic: Neurological; Subtopic: Neurological (all Subtopics); Disease: Nervous system disorders
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Participants - inclusion criteria
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Any patient (over 16 years) undergoing craniotomy in Wessex Neurological Centre
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Participants - exclusion criteria
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1. Aged less than 16 years
2. Pregnancy
3. Prisoners
4. Patients incapable of consent
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Anticipated start date
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01/06/2007
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Anticipated end date
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01/06/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet
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Target number of participants
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Planned sample size: 200
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Interventions
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Any patient undergoing craniotomy in the Wessex Neurological Centre will be considered. Appropriate consent will be obtained from the patient. At surgery up to five image acquisitions will be made. Each image acquisition will last up to 2 minutes and will consist of the full spectral analysis at fixed points followed by field images of fixed wavelengths. A photographic image and copy of the MRI scan will also be take to correlate spectral traces with conventional means of identifying normal and abnormal tissue. These images will then be analysed post-operatively and not be used to guide surgery or influence patient management.
The main arm of the trial will attempt to differentiate normal and abnormal brain. This will be done in patients under general anaesthetic as described above. The second arm will try to assess if the reflectance of the brain changes with function. This will be a smaller cohort of patients, as they will be undergoing awake craniotomy. During surgery images will be obtained before and during basic tasks performed for standard cortical mapping such as speech and hand squeezing to assess for any changes.
Data will be collected on a laptop computer before applying noise reduction and normalising data. Graphical representations of spectroscopic traces will be assessed for unusual signatures and differences between pathological and non-pathological tissue and between functioning and non-functioning cortex assess using a student’s t-test. Data will be stored anonymously on a networked university computer for up to ten years.
The duration on the intervention is 10 minutes added to the usual surgery time. This group of patients are not followed up for trial purposes. There are no treatment arms here: images are acquired for research purposes without any management implications for the individual patients.
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Primary outcome measure(s)
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Difference in reflection between normal brain tissue and abnormal brain tissue, acquired at the time of image acquisition
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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National Institute for Health Research (NIHR) (UK) - Central Commissioning Facility (CCF): New and Emerging Applications of Technology (NEAT) Programme
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Trial website
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Publications
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Contact name
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Prof
William
Gray
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Address
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Division of Clinical Neurosciences
Tremona Road
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City/town
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Southampton
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Zip/Postcode
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SO16 6YD
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Country
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United Kingdom
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Email
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cnsadmin@soton.ac.uk
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Sponsor
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University of Southampton (UK)
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Address
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Aldermoor Close
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City/town
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Southampton
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Zip/Postcode
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SO16 5ST
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Country
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United Kingdom
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Sponsor website:
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http://www.soton.ac.uk/
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Date applied
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30/06/2010
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Last edited
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18/08/2010
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Date ISRCTN assigned
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30/06/2010
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