Intra-operative Hyperspectral Imaging in Neurosurgery

NCT05294185 | Unknown

• 1 other identifier: 284230
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Neurosurgery; Neurovascular; Neuro-Oncology

Keywords

Hyperspectral imaging; Tissue perfusion; Tissue oxygenation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Tissue perfusion and tissue oxygenation

  36 months

• Safety of iHSI in Neurosurgery

  36 months

• AI algorithm specificity

  36 months

• Qualitative assessment

  36 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing neuro-oncology and neurovascular surgery

You may qualify if:

• 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

You may not qualify if:

• Patients under 18 years of age
• Patients who have previously had brain surgery

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

King's College NHS Foundation Trust

London, SE5 9RS, United Kingdom

RECRUITING

Study Officials

• Jonathan Shapey

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Shapey

CONTACT

02078365454; Jonathan.shapey@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 24, 2022
• Study Start: May 17, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

GB (1)