A spectral analysis of human brain tissue

ISRCTN	ISRCTN37780318
DOI	https://doi.org/10.1186/ISRCTN37780318
Secondary identifying numbers	7568

Submission date: 30/06/2010
Registration date: 30/06/2010
Last edited: 04/10/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof William Gray
Scientific

Division of Clinical Neurosciences
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Email	cnsadmin@soton.ac.uk

Study information

Study design	Single-centre non-randomised interventional diagnosis and screening trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	GP practice
Study type	Diagnostic
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	A spectral analysis of human brain tissue: a single-centre non-randomised intra-operative imaging trial
Study objectives	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.
Ethics approval(s)	Southampton and Southwest Hampshire Research Ethics Committee, 22/02/2007, ref: 06/Q1704/139
Health condition(s) or problem(s) studied	Topic: Neurological; Subtopic: Neurological (all Subtopics); Disease: Nervous system disorders
Intervention	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.
Intervention type	Other
Primary outcome measure	Difference in reflection between normal brain tissue and abnormal brain tissue, acquired at the time of image acquisition
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/06/2007
Completion date	01/06/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned sample size: 200
Key inclusion criteria	Any patient (over 16 years) undergoing craniotomy in Wessex Neurological Centre
Key exclusion criteria	1. Aged less than 16 years 2. Pregnancy 3. Prisoners 4. Patients incapable of consent
Date of first enrolment	01/06/2007
Date of final enrolment	01/06/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Southampton General Hospital

Southampton
SO16 6YD
United Kingdom

Sponsor information

University of Southampton (UK)
University/education

Aldermoor Close
Southampton
SO16 5ST
England
United Kingdom

Website	http://www.soton.ac.uk/
"ROR"	https://ror.org/01ryk1543

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Central Commissioning Facility (CCF): New and Emerging Applications of Technology (NEAT) Programme

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

04/10/2017: No publications found in PubMed, verifying study status with principal investigator.