search
Back to results

Use of Non-invasive Optical Analysis in Neurosurgery

Primary Purpose

Brain Tumour, Glioma, Meningioma

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Intra-operative multispectral / hyperspectral analysis
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Brain Tumour focused on measuring gliomas, multispectral analysis, hyperspectral analysis, fluorescence, brain tumours

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Imperial College NHS Trust, Charing Cross HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with brain tumours candidate for neurosurgery

Arm Description

Patients will be recruited following the inclusion criteria: any patient with a diagnosis of brain tumour, age ranging from 18 with no upper limit, who will agree to the operation and to take part of the present study, will be enrolled. During surgery, multispectral and/or hyper spectral acquisition of images from the surgical field will be performed. Each patient will have an average acquisition of 6 datasets. As each dataset will correspond to an image, this will be divided into many reading regions (from 10 to 20) for a total of approximatively 60 measurements per patient.

Outcomes

Primary Outcome Measures

Analysis of spectroscopic signal reading between brain tissue and brain tumour
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
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 Outcome Measures

Analysis of spectroscopic signal reading of surgical field as seen at its baseline and under fluorescence-specific light
Comparison will be made between multispectral / hyper spectral acquired images, and the same images acquired with the addition of fluorescence light

Full Information

First Posted
March 24, 2020
Last Updated
April 24, 2023
Sponsor
Imperial College London
search

1. Study Identification

Unique Protocol Identification Number
NCT04712214
Brief Title
Use of Non-invasive Optical Analysis in Neurosurgery
Official Title
Use of Non-invasive Optical Analysis in Neurosurgery - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2021 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumour, Glioma, Meningioma, Brain Metastases, Schwannoma
Keywords
gliomas, multispectral analysis, hyperspectral analysis, fluorescence, brain tumours

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with brain tumours candidate for neurosurgery
Arm Type
Experimental
Arm Description
Patients will be recruited following the inclusion criteria: any patient with a diagnosis of brain tumour, age ranging from 18 with no upper limit, who will agree to the operation and to take part of the present study, will be enrolled. During surgery, multispectral and/or hyper spectral acquisition of images from the surgical field will be performed. Each patient will have an average acquisition of 6 datasets. As each dataset will correspond to an image, this will be divided into many reading regions (from 10 to 20) for a total of approximatively 60 measurements per patient.
Intervention Type
Device
Intervention Name(s)
Intra-operative multispectral / hyperspectral analysis
Intervention Description
During surgery, the operating surgeon will be using standard NHS neurosurgical equipment such as an endoscope and/or a microscope. This equipment is operated in exactly the same way as with any other procedure, but either the microscope or the endoscope in use will be connected to the system of camera and filters for multispectral/hyperspectral analysis. During each surgical intervention, tissue-specific spectral data will be collected at specific stages - mostly once the brain surface is exposed and at the end of the resection on the surgical cavity. The operation will be visually recorded in order to sync visual data with the spectral data obtained at the same moment in time. The video recording will not be patient identifiable and will be viewed only by members of the research team working on this project (see below). The use of video recording equipment will be included in the patient information sheet given to all patients prior to gaining consent
Primary Outcome Measure Information:
Title
Analysis of spectroscopic signal reading between brain tissue and brain tumour
Description
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).
Time Frame
3 years
Title
Analysis of spectroscopic signal reading between functional brain areas and non functional brain areas
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Analysis of spectroscopic signal reading of surgical field as seen at its baseline and under fluorescence-specific light
Description
Comparison will be made between multispectral / hyper spectral acquired images, and the same images acquired with the addition of fluorescence light
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giulio Anichini, MD, FEBNS
Phone
00447460946298
Email
g.anichini@imperial.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin O'Neill, MD, FRCS
Organizational Affiliation
Imperial College of London, Charing Cross Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Imperial College NHS Trust, Charing Cross Hospital
City
London
State/Province
England
ZIP/Postal Code
W68RF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giulio Anichini
Phone
00447460946298
Email
g.anichini@imperial.ic.uk
First Name & Middle Initial & Last Name & Degree
Kevin O'Neill
Phone
02033117489
Email
Kevin.ONeill@imperial.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28957220
Citation
Behrooz A, Waterman P, Vasquez KO, Meganck J, Peterson JD, Faqir I, Kempner J. Multispectral open-air intraoperative fluorescence imaging. Opt Lett. 2017 Aug 1;42(15):2964-2967. doi: 10.1364/OL.42.002964.
Results Reference
background
PubMed Identifier
28063974
Citation
Lu HD, Chen G, Cai J, Roe AW. Intrinsic signal optical imaging of visual brain activity: Tracking of fast cortical dynamics. Neuroimage. 2017 Mar 1;148:160-168. doi: 10.1016/j.neuroimage.2017.01.006. Epub 2017 Jan 4.
Results Reference
background
PubMed Identifier
26309761
Citation
Fawzy Y, Lam S, Zeng H. Rapid multispectral endoscopic imaging system for near real-time mapping of the mucosa blood supply in the lung. Biomed Opt Express. 2015 Jul 21;6(8):2980-90. doi: 10.1364/BOE.6.002980. eCollection 2015 Aug 1.
Results Reference
background
PubMed Identifier
28149926
Citation
Zhang Y, Wirkert SJ, Iszatt J, Kenngott H, Wagner M, Mayer B, Stock C, Clancy NT, Elson DS, Maier-Hein L. Tissue classification for laparoscopic image understanding based on multispectral texture analysis. J Med Imaging (Bellingham). 2017 Jan;4(1):015001. doi: 10.1117/1.JMI.4.1.015001. Epub 2017 Jan 25.
Results Reference
background

Learn more about this trial

Use of Non-invasive Optical Analysis in Neurosurgery

We'll reach out to this number within 24 hrs