Advanced hyperspectral imaging during brain tumour surgery
| ISRCTN | ISRCTN23639281 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23639281 |
| IRAS number | 284230 |
| ClinicalTrials.gov number | NCT05294185 |
| Secondary identifying numbers | IRAS 284230, CPMS 51752 |
- Submission date
- 04/04/2022
- Registration date
- 01/06/2022
- Last edited
- 23/08/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English Summary
Background and study aims
Brain surgery operations include brain tumour resection and procedures relating to blood vessel abnormalities. Each year in the UK, about 70,500 patients are diagnosed with a brain tumour, 5,000 of whom undergo surgery. About 1,000 patients undergo blood vessel surgery. There is an acute need to improve outcomes for affected brain tumour patients. Patients undergoing surgery have significantly improved outcomes and increased life expectancy if complete tumour removal is achieved. However, close to 30% of patients are left with residual tumour tissue after surgery. Successful surgery indeed mandates maximal safe tumour removal: surgeons need to avoid damaging sensitive areas that undertake vital functions and preserve crucial nerves and blood vessels. Even with the most advanced current techniques, it is not possible to always reliably identify the tumour and critical structures during surgery. Furthermore, because one cannot objectively measure the blood supply and oxygenation of brain tissue during surgery, it is difficult to judge if the injury is being caused during the operation. The aim of this study is to obtain images during brain surgery using a new type of surgical non-contact camera system. The study will obtain video images at the various stages of the operation. This will not alter the operation performed. The data obtained will also be used to develop the system’s key computer-processing features. This will enable real-time information to be given to the surgeon whilst they are performing the procedure and has the potential to make neurosurgery safer and more precise.
Who can participate?
Patients aged 18 years and over who are scheduled for elective surgery for a diagnosis of a brain tumour, an arteriovenous malformation, or an intracranial aneurysm
What does the study involve?
The study involves taking additional video images during neuro-oncology and neurovascular operations which will extend the operation by up to 15 minutes. The operation will be completed in the usual manner and the surgeon will not use any of the acquired intraoperative data to guide surgical management.
What are the possible benefits and risks of participating?
There will be no immediate direct benefits to those taking part, but the information acquired from this study will help improve the future treatment of people undergoing brain surgery.
Where is the study run from?
King’s College NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
September 2021 to June 2025
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Mr Jonathan Shapey
Jonathan.shapey@kcl.ac.uk
Contact information
Principal Investigator
9th Floor
Becket House
1 Lambeth Palace Road
London
SE1 7EU
United Kingdom
| Phone | +44 (0)20 7836 5454 |
|---|---|
| Jonathan.shapey@kcl.ac.uk |
Scientific
9th Floor
Becket House
1 Lambeth Palace Road
London
SE1 7EU
United Kingdom
| Phone | +44 (0)20 7836 5454 |
|---|---|
| Jonathan.shapey@kcl.ac.uk |
Public
Denmark Hill
London
SE5 9RS
United Kingdom
| Phone | +44 (0)203 299 9000 |
|---|---|
| coordinator@neurohsi.uk |
Study information
| Study design | Single-centre cohort observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A prospective observational study to evaluate the use of an intraoperative hyperspectral imaging system in neurosurgery |
| Study acronym | NeuroHSI |
| Study hypothesis | To correlate hyperspectral imaging data with analysis of the corresponding biopsied brain tumour tissue and to correlate intraoperative blood supply and oxygenation levels generated from the hyperspectral imaging (HSI) data with the surgical timeline in patients undergoing blood vessel surgery. |
| Ethics approval(s) | Approved 23/02/2022, London - Westminster Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA, UK; +44 (0)207 104 8066; abitha.paimpillichalil@hra.nhs.uk), ref: 22/LO/0046 |
| Condition | Neurosurgery |
| Intervention | In this project, the researchers will use a HSI imaging system to record data in 81 patients undergoing brain including 63 patients with brain tumours and 18 patients suffering from brain vessel abnormalities. Using this data they will develop key computer-processing features to enable real-time image interpretation. |
| Intervention type | Other |
| Primary outcome measure | Intraoperative oxygenation evaluated using hyperspectral imaging data at 5-10 data points within a 15-minute intraoperative period |
| Secondary outcome measures | 1. Imaging data relevant to the primary pathology acquired at 3 months 2. Any adverse events regarding the safety of the study will be recorded in the first 3 months |
| Overall study start date | 15/09/2021 |
| Overall study end date | 30/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 81 |
| Participant inclusion criteria | 1. Adult patients aged 18 years and over 2. Patients with a diagnosis of a brain tumour (any type), arteriovenous malformation (AVM) or aneurysm who are scheduled for elective surgery 3. Patients able to provide written informed consent |
| Participant exclusion criteria | 1. Patients under 18 years of age 2. Patients who have previously had brain surgery |
| Recruitment start date | 01/04/2022 |
| Recruitment end date | 30/06/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SE5 9RS
United Kingdom
Sponsor information
University/education
Room 5.31
James Clerk Maxwell Building
57 Waterloo Road
London
SE1 8WA
England
United Kingdom
| Phone | +44 (0)2078483224 |
|---|---|
| reza.razavi@kcl.ac.uk | |
| Website | http://www.kcl.ac.uk/index.aspx |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Results from this study will be used as part of an educational project (e.g. PhD). Results from this research study will be made publicly available through the study website (https://www.neurohsi.uk) and through the publication of open-access research papers, presentation of results at scientific meetings, patient events, and online via King’s College London and relevant charity websites/social media. All identifiable personal data used for research will be anonymised before the publication of the results. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
23/08/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 02/08/2024 to 30/06/2025.
2. The overall study end date was changed from 02/08/2024 to 30/06/2025.
3. The intention to publish date was changed from 02/08/2025 to 30/09/2025.
04/07/2022: Internal review.
12/04/2022: Trial's existence confirmed by the NIHR and HRA.
