NeurosurgeryNeuro-qFHSINCT05397574
Intraoperative Hyperspectral Imaging for Fluorescence Guided Surgery in Low Grade Gliomas
An observational study of Neurosurgery and Neuro-Oncology, run by King's College London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurosurgery, Neuro-Oncology, Brain Tumor
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2022to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing glioma surgery
Who may be able to join
- 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
Who cannot join
- Patients under 18 years of age
- Patients who have previously had brain surgery
- Patients unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College NHS Foundation Trust
London, SE5 9RS
Jonathan Shapey, 0203 299 9000 ext. 38001, Jonathan.shapey@kcl.ac.uk
Jonathan Shapey
About this study
Official title: 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.
Read the 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.
- Conditions
- Neurosurgery, Neuro-Oncology, Brain Tumor
- Medical subject headings
- Brain Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6-12 months
Secondary outcomes (4)
Safety of qFHSI in surgery
To demonstrate safety of our intraoperative qFHSI device during glioma surgery
Measured: 24-36 months
Tissue diagnosis
To collect ex vivo and in vivo qFHSI data during glioma surgery for tissue analysis, algorithmic development and testing
Measured: 24 months
Accuracy of biophotonics algorithm
To evaluate accuracy of the computational biophotonics algorithm to determine 5-ALA-PpIX concentration in imaged tissue
Measured: 24-36 months
Qualitative assessment
A qualitative assessment of the impact that using the device has on surgical workflow
Measured: 24-36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 Sep 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurosurgeryStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397574
- Sponsor's protocol ID
- 307291
- Acronym
- Neuro-qFHSI
- Status last verified
- Nov 2023
- First submitted
- 25 May 2022
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Hyperspectral Imaging for Real-time Fluorescence-guided Surgery of Low Grade Glioma
- ClinicalTrials.gov ID
- NCT05397574
- Acronym / sponsor ID
- Neuro-qFHSI / 307291
- Conditions
- Neurosurgery, Neuro-Oncology, Brain Tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing glioma surgery
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients under 18 years of age
- Patients who have previously had brain surgery
- Patients unable to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of qFHSI data with histological analysis of the corresponding biopsied pathological tissue
Time frame: 6-12 months
To correlate ex vivo and in vivo qFHSI data with histological analysis of the corresponding biopsied glioma tissue
4 secondary outcomes
Safety of qFHSI in surgery
Time frame: 24-36 months
Tissue diagnosis
Time frame: 24 months
Accuracy of biophotonics algorithm
Time frame: 24-36 months
Qualitative assessment
Time frame: 24-36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
King's College NHS Foundation Trust
London, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurosurgery and Neuro-Oncology, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of qFHSI data with histological analysis of the corresponding biopsied pathological tissue (time frame: 6-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.