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Clinical Trials/NCT04712214
NCT04712214
Recruiting
Not Applicable

Use of Non-invasive Optical Analysis in Neurosurgery - A Pilot Study

Imperial College London1 site in 1 country50 target enrollmentMarch 28, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Tumour
Sponsor
Imperial College London
Enrollment
50
Locations
1
Primary Endpoint
Analysis of spectroscopic signal reading between brain tissue and brain tumour
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

The present study aims to investigate the potential application of multispectral analysis, hyperspectral imaging, and fluorescence during neuro-oncological procedures, specifically during brain tumour debulking / resection. These optics techniques are entirely non-invasive and consist in camera with a filter to be linked to the standard microsurgical and endoscopic instruments used in theatre. The research procedure consists of images acquisition and data processing, with virtually no additional invasive procedures to be performed on patients.

Detailed Description

Surgical resection of brain tumours remains a challenge. While the center of a tumour is easily resectable, its margins are often fading into normal brain, and therefore quite difficult to identify. Moreover, there is now extensive literature proving that tumour cells extend way beyond visible margins of a tumour, following white matter tracts in the brain. As opposite to different organs (such as liver or kidney), resection of brain tumours beyond the visible margins is limited by the presence of eloquent/functional areas. Damages or resection of these areas will inevitably cause a permanent disability, which can be incredibly serious and impact on further treatment: a paralyzed or unconscious patient is not capable of tolerating chemotherapy or radiotherapy after surgery, both crucial complementary forms of treatment to contain the disease, in combination with surgery. Because of these premises, the concept of "functional margins of resection" is now established in the neurosurgical community: a tumour is resected and the resection is pushed up to 1-2 cms beyond the margins or only up to the point where a functional/eloquent area is found. If the latter is the case, the functional area is obviously preserved and tumour resection is stopped. Identifying these areas is the main challenge in brain tumour surgery. The aim of this study and its scientific justification is to refine a new, potentially more practical and quick technique to identify functional brain areas in real time. This study can serve as a benchmark study to both improve surgery of brain tumours and increase our knowledge about brain tumours and eloquent brain vascular supply. This technique can also potentially be implemented to obtain a novel technology to assess brain perfusion during neurosurgical procedures. Maintaining blood supply to healthy brain tissue is a key component of successful neuro-oncological surgery. Multispectral/hyperspectral analysis can be evaluated as a complementary tool to assess brain perfusion in real-time and prevent post-operative devastating neurological complications, such as strokes, or significantly reduce the secondary damage would these complications occurr. The present project consists of a pilot observational study on patients diagnosed with brain tumours candidate for a neurosurgical operation. From a practical point of view, participation in the study will only imply that some images will be acquired during surgery and processed at a later stage. The study won't impact on patients' care at any stage, nor will produce results that will be relevant for future medical records of patients enrolled. Patients will be approached about this study at the time of their first neuro-oncology clinic consultation. A member of the research team will be present at the time of the consultation and will explain in details what are the purposes and the methods of the present study.

Registry
clinicaltrials.gov
Start Date
March 28, 2021
End Date
October 30, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Candidates for surgery due to a confirmed clinical and radiological diagnosis of cranial intrinsic or extrinsic tumour - any histological diagnosis confirming neuro-oncological disease, including primary and secondary disease
  • Agreed to take part to the present research protocol and signed proper informed consent form

Exclusion Criteria

  • Suspected differential diagnosis of pathological condition affecting central nervous system other than neuro-oncological disease - including demyelinating diseases, infections, brain traumas / haematomas, vascular or auto-immune diseases
  • Patients not capable to give consent - not in condition of understanding, processing and retaining information

Outcomes

Primary Outcomes

Analysis of spectroscopic signal reading between brain tissue and brain tumour

Time Frame: 3 years

Brain tissue and tumour tissue, the signals collected will be correlated both to the visual signal seen on normal operative field, a pre-set of brain images, and the signal seen on the peri-operative imaging (MRI scan).

Analysis of spectroscopic signal reading between functional brain areas and non functional brain areas

Time Frame: 3 years

The signal collected will be correlated with the neuro-physiological intra-operative findings, in every case there is an indication to do so, and with the expected location of the eloquent areas on the peri-operative images.

Secondary Outcomes

  • Analysis of spectroscopic signal reading of surgical field as seen at its baseline and under fluorescence-specific light(3 years)

Study Sites (1)

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