Clinical trial NCT05294185: Intra-operative Hyperspectral Imaging in Neurosurgery
Official title: A Prospective Observational Study to Evaluate the Use of an Intraoperative Hyperspectral Imaging System in Neurosurgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurosurgery
Neurovascular
Neuro-Oncology
Keywords: Hyperspectral imaging
Tissue perfusion
Tissue oxygenation
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing neuro-oncology and neurovascular surgery

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.


Eligibility criteria: 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

Primary outcomes:
measure: Correlation of HSI data with histological analysis of the corresponding biopsied pathological tissue
timeFrame: 4-6 months
Secondary outcomes:
measure: Tissue perfusion and tissue oxygenation
timeFrame: 36 months
measure: Safety of iHSI in Neurosurgery
timeFrame: 36 months
measure: AI algorithm specificity
timeFrame: 36 months
measure: Qualitative assessment
timeFrame: 36 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College NHS Foundation Trust
Study officials:
affiliation: King's College London
name: Jonathan Shapey
role: PRINCIPAL_INVESTIGATOR
References: