Intraoperative Hyperspectral Imaging for Fluorescence Guided Surgery in Low Grade Gliomas (Neuro-qFHSI)

Intraoperative Hyperspectral Imaging for Real-time Fluorescence-guided Surgery of Low Grade Glioma

The purpose of this study is to obtain images of brain tumours during surgery using a new type of surgical camera. The study will assess how the information obtained from the images during surgery matches the removed tissue. Data will also be used to develop the system's key computer-processing features. This will enable real-time information to be given to the surgeon whilst they are performing the procedure and has the potential to make neurosurgery safer and more precise.

Study Overview

• Status: Recruiting
• Conditions: Brain Tumor; Neurosurgery; Neuro-Oncology

Detailed Description

High grade gliomas (HGG) and low grade gliomas (LGG) are the commonest CNS cancers, with LGGs accounting for 6.4% of all adult cases (Ostrom 2019). Despite LGGs typically being slow-growing, over 70% of them transform into higher-grade tumours or become aggressive within a decade (Jooma 2019). Median survival for LGG patients spans 5.6 to 13.3 years (Brown 2019). Gross total resection (GTR) improves 5-year LGG survival rates from 60% to 90% when compared to subtotal resection. However, GTR (>96% tumour removal) is frequently not achieved because despite advanced techniques being available, surgeons are unable to clearly visualise the tumour and its boundaries in real-time during surgery.

There is an acute need to improve outcomes for affected brain tumour patients. Patients undergoing surgery have significantly improved outcomes and increased life expectancy if complete tumour removal is achieved. However, close to 30% of patients are left with residual tumour tissue after surgery. Successful surgery indeed mandates maximal safe tumour removal: surgeons need to avoid damaging sensitive areas that undertake vital functions and preserve crucial nerves and blood vessels. Even with the most advanced current techniques, it is not possible to always identify tumour and critical structures reliably during surgery. Furthermore, because one cannot objectively measure the blood supply and oxygenation of brain tissue during surgery, it is difficult to judge if injury is being caused during the operation.

To address the pressing clinical need of improved surgical precision and patient safety during low grade glioma surgery, we aim to develop an imaging system capable of quantitative wide-field fluorescence imaging for seamless real-time surgical guidance. This project aims to improve patient survival by delivering a precise assistive tool for neurosurgeons performing LGG surgery by evaluating this device in patients undergoing glioma surgery.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • Recruiting
    • King's College NHS Foundation Trust
    • Principal Investigator: Jonathan Shapey
    • Contact: Jonathan Shapey; Phone Number: 38001 0203 299 9000; Email: Jonathan.shapey@kcl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing glioma surgery

Description

Inclusion Criteria:

• Adult patients aged 18 years and over
• Patients with a diagnosis of a probable glioma (any grade), 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
• Patients unable to provide written informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of qFHSI data with histological analysis of the corresponding biopsied pathological tissue	To correlate ex vivo and in vivo qFHSI data with histological analysis of the corresponding biopsied glioma tissue	6-12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of qFHSI in surgery	To demonstrate safety of our intraoperative qFHSI device during glioma surgery	24-36 months
Tissue diagnosis	To collect ex vivo and in vivo qFHSI data during glioma surgery for tissue analysis, algorithmic development and testing	24 months
Accuracy of biophotonics algorithm	To evaluate accuracy of the computational biophotonics algorithm to determine 5-ALA-PpIX concentration in imaged tissue	24-36 months
Qualitative assessment	A qualitative assessment of the impact that using the device has on surgical workflow	24-36 months

Collaborators and Investigators

• Sponsor: King's College London

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): December 7, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: 307291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No