Condition category
Nervous System Diseases
Date applied
30/06/2010
Date assigned
30/06/2010
Last edited
02/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof William Gray

ORCID ID

Contact details

Division of Clinical Neurosciences
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
-
cnsadmin@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7568

Study information

Scientific title

A spectral analysis of human brain tissue: a single-centre non-randomised intra-operative imaging trial

Acronym

Study hypothesis

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

Southampton and Southwest Hampshire Research Ethics Committee, 22/02/2007, ref: 06/Q1704/139

Study design

Single-centre non-randomised interventional diagnosis and screening trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

GP practices

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/06/2007

Overall trial end date

01/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Any patient (over 16 years) undergoing craniotomy in Wessex Neurological Centre

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 200

Participant exclusion criteria

1. Aged less than 16 years
2. Pregnancy
3. Prisoners
4. Patients incapable of consent

Recruitment start date

01/06/2007

Recruitment end date

01/06/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southampton General Hospital
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

University of Southampton (UK)

Sponsor details

Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Sponsor type

University/education

Website

http://www.soton.ac.uk/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes