Intra-operative Hyperspectral Imaging in Neurosurgery (NeuroHSI)

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.

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 Overview

• Status: Recruiting
• Conditions: Neurosurgery; Neurovascular; Neuro-Oncology

• Study Type: Observational
• Enrollment (Estimated): 81

Contacts and Locations

• Study Contact: Name: Jonathan Shapey; Phone Number: 02078365454; Email: Jonathan.shapey@kcl.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • Recruiting
    • King's College NHS Foundation Trust
    • Contact: Jonathan Shapey; Email: Jonathan.shapey@kcl.ac.uk
    • Principal Investigator: Jonathan Shapey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing neuro-oncology and neurovascular surgery

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	36 months
Safety of iHSI in Neurosurgery	Record of adverse events	36 months
AI algorithm specificity	Specificity of the AI algorithm to determine the histological nature of imaged tissue	36 months
Qualitative assessment	The impact that using the system has on surgical workflow (qualitative assessment)	36 months

Collaborators and Investigators

• Sponsor: King's College London
• Investigators: Principal Investigator: Jonathan Shapey, King's College London

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Tissue oxygenation; Hyperspectral imaging; Tissue perfusion
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 284230

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No