NeurosurgeryNeuroHSINCT05294185
Intra-operative Hyperspectral Imaging in Neurosurgery
An observational study of Neurosurgery and Neurovascular, run by King's College London at 1 site in United Kingdom.
Trial summary
Brain surgery operations include brain tumour removal and blood vessel procedures. Each year in the UK, approximately 70,500 patients are diagnosed with a brain tumour, 5,000 of whom undergo surgery. Approximately 1,000 patients undergo blood vessel brain surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurosurgery, Neurovascular, Neuro-Oncology
- How many people
- 81 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 May 2022to Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing neuro-oncology and neurovascular surgery
Who may be able to join
- Adult patients aged 18 years and over
- Patients with a diagnosis of a brain tumour (any type), AVM or aneurysm who are scheduled for elective surgery
- Patients able to provide written informed consent
Who cannot join
- Patients under 18 years of age
- Patients who have previously had brain surgery
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College NHS Foundation Trust
London, SE5 9RS
Jonathan Shapey, Jonathan.shapey@kcl.ac.uk
Jonathan Shapey
About this study
Official title: A Prospective Observational Study to Evaluate the Use of an Intraoperative Hyperspectral Imaging System in Neurosurgery
Brain surgery operations include brain tumour removal and blood vessel procedures. Each year in the UK, approximately 70,500 patients are diagnosed with a brain tumour, 5,000 of whom undergo surgery. Approximately 1,000 patients undergo blood vessel brain surgery.
Brain tumour surgery involves removing as much of the tumour as safely as possible. If all tumour is removed, patients have significantly better outcomes and live longer. However, even with the best hands and the most modern technology currently available, it is often not possible to reliably identify tumour during surgery. Moreover, nerves and blood vessels cannot be reliably identified either during surgery. Yet, they need to be preserved to avoid brain damage. Due to this uncertainty and the need to balance risks, tumour is often left behind. Today, close to 30% of brain tumour patients require repeat surgery owing to tumour left behind during their first surgery. Further surgeries are more difficult, pose additional patient risks and lead to increased healthcare costs with often poor patient outcomes.
Read more
Newly developed camera systems have the potential to enhance the surgeon's vision to reliably identify tumour and healthy brain structures. Hyperspectral imaging (HSI) is one of the most promising of such technologies. Its core ability is to provide very detailed and rich information that is invisible to the human eye. HSI has demonstrated the potential to provide crucial, but currently unavailable, information about tumour and critical brain structures during surgery. However, HSI data is very complex and requires advanced computer-processing for its interpretation.
In this project, we will use a HSI imaging system to record data in 81 patient undergoing brain including 63 patients with brain tumours and 18 patients suffering from brain vessel abnormalities. Using this data we will develop key computer-processing features to enable real-time image interpretation.
- Conditions
- Neurosurgery, Neurovascular, Neuro-Oncology
- Keywords
- Hyperspectral imaging, Tissue perfusion, Tissue oxygenation
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of HSI data with histological analysis of the corresponding biopsied pathological tissue
To correlate HSI data with histological analysis of the corresponding biopsied pathological tissue and to correlate tissue perfusion and tissue oxygenation maps generated from the HSI data with the surgical timeline in patients undergoing neurovascular surgery.
Measured: 4-6 months
Secondary outcomes (4)
Tissue perfusion and tissue oxygenation
Correlation of tissue perfusion and tissue oxygenation maps generated from the HSI data with the surgical timeline in patients undergoing neurovascular surgery
Measured: 36 months
Safety of iHSI in Neurosurgery
Record of adverse events
Measured: 36 months
AI algorithm specificity
Specificity of the AI algorithm to determine the histological nature of imaged tissue
Measured: 36 months
Qualitative assessment
The impact that using the system has on surgical workflow (qualitative assessment)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start17 May 2022
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurosurgeryStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Shapey, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294185
- Sponsor's protocol ID
- 284230
- Acronym
- NeuroHSI
- Status last verified
- Nov 2023
- First submitted
- 11 Mar 2022
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study to Evaluate the Use of an Intraoperative Hyperspectral Imaging System in Neurosurgery
- ClinicalTrials.gov ID
- NCT05294185
- Acronym / sponsor ID
- NeuroHSI / 284230
- Conditions
- Neurosurgery, Neurovascular, Neuro-Oncology
- Keywords
- Hyperspectral imaging, Tissue perfusion, Tissue oxygenation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 17 May 2022 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brain surgery operations include brain tumour removal and blood vessel procedures. Each year in the UK, approximately 70,500 patients are diagnosed with a brain tumour, 5,000 of whom undergo surgery. Approximately 1,000 patients undergo blood vessel brain surgery.
Brain tumour surgery involves removing as much of the tumour as safely as possible. If all tumour is removed, patients have significantly better outcomes and live longer. However, even with the best hands and the most modern technology currently available, it is often not possible to reliably identify tumour during surgery. Moreover, nerves and blood vessels cannot be reliably identified either during surgery. Yet, they need to be preserved to avoid brain damage. Due to this uncertainty and the need to balance risks, tumour is often left behind. Today, close to 30% of brain tumour patients require repeat surgery owing to tumour left behind during their first surgery. Further surgeries are more difficult, pose additional patient risks and lead to increased healthcare costs with often poor patient outcomes.
Newly developed camera systems have the potential to enhance the surgeon's vision to reliably identify tumour and healthy brain structures. Hyperspectral imaging (HSI) is one of the most promising of such technologies. Its core ability is to provide very detailed and rich information that is invisible to the human eye. HSI has demonstrated the potential to provide crucial, but currently unavailable, information about tumour and critical brain structures during surgery. However, HSI data is very complex and requires advanced computer-processing for its interpretation.
In this project, we will use a HSI imaging system to record data in 81 patient undergoing brain including 63 patients with brain tumours and 18 patients suffering from brain vessel abnormalities. Using this data we will develop key computer-processing features to enable real-time image interpretation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing neuro-oncology and neurovascular surgery
Key inclusion criteria (3 listed)
- Adult patients aged 18 years and over
- Patients with a diagnosis of a brain tumour (any type), AVM or aneurysm who are scheduled for elective surgery
- Patients able to provide written informed consent
Key exclusion criteria (2 listed)
- Patients under 18 years of age
- Patients who have previously had brain surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of HSI data with histological analysis of the corresponding biopsied pathological tissue
Time frame: 4-6 months
To correlate HSI data with histological analysis of the corresponding biopsied pathological tissue and to correlate tissue perfusion and tissue oxygenation maps generated from the HSI data with the surgical timeline in patients undergoing neurovascular surgery.
4 secondary outcomes
Tissue perfusion and tissue oxygenation
Time frame: 36 months
Safety of iHSI in Neurosurgery
Time frame: 36 months
AI algorithm specificity
Time frame: 36 months
Qualitative assessment
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Shapey principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurosurgery and Neurovascular, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Shapey (02078365454, Jonathan.shapey@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of HSI data with histological analysis of the corresponding biopsied pathological tissue (time frame: 4-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.