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Intra-operative Hyperspectral Imaging in Neurosurgery (NeuroHSI)

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ClinicalTrials.gov Identifier: NCT05294185
Recruitment Status : Not yet recruiting
First Posted : March 24, 2022
Last Update Posted : May 23, 2022
Sponsor:
Information provided by (Responsible Party):
King's College London

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.


Condition or disease
Neurosurgery Neurovascular Neuro-Oncology

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Study Type : Observational
Estimated Enrollment : 81 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study to Evaluate the Use of an Intraoperative Hyperspectral Imaging System in Neurosurgery
Estimated Study Start Date : May 18, 2022
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Tissue perfusion and tissue oxygenation [ Time Frame: 36 months ]
    Correlation of tissue perfusion and tissue oxygenation maps generated from the HSI data with the surgical timeline in patients undergoing neurovascular surgery

  2. Safety of iHSI in Neurosurgery [ Time Frame: 36 months ]
    Record of adverse events

  3. AI algorithm specificity [ Time Frame: 36 months ]
    Specificity of the AI algorithm to determine the histological nature of imaged tissue

  4. Qualitative assessment [ Time Frame: 36 months ]
    The impact that using the system has on surgical workflow (qualitative assessment)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing neuro-oncology and neurovascular surgery
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05294185


Contacts
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Contact: Jonathan Shapey 02078365454 Jonathan.shapey@kcl.ac.uk

Locations
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United Kingdom
King's College NHS Foundation Trust
London, United Kingdom, SE5 9RS
Contact: Jonathan Shapey       Jonathan.shapey@kcl.ac.uk   
Principal Investigator: Jonathan Shapey         
Sponsors and Collaborators
King's College London
Investigators
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Principal Investigator: Jonathan Shapey King's College London
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT05294185    
Other Study ID Numbers: 284230
First Posted: March 24, 2022    Key Record Dates
Last Update Posted: May 23, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by King's College London:
Hyperspectral imaging
Tissue perfusion
Tissue oxygenation
Additional relevant MeSH terms:
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Neoplasms