Intra-operative Hyperspectral Imaging in Neurosurgery

NCT ID: NCT05294185

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-17

Study Completion Date

2024-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neurosurgery Neurovascular Neuro-Oncology

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Hyperspectral imaging Tissue perfusion Tissue oxygenation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Patients under 18 years of age
* Patients who have previously had brain surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

King's College London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jonathan Shapey

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

King's College NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jonathan Shapey

Role: CONTACT

Phone: 02078365454

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jonathan Shapey

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

284230

Identifier Type: -

Identifier Source: org_study_id