GliomaEDGENCT04556929
Enhanced Detection in Glioma Excision
A study testing Intra-operative imaging of 5-ALA fluorescence using ultra-high sensitivity camera, Intra-operative imaging of 5-ALA fluorescence using in-built operative microscope camera and Biopsies in people with Glioma, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine whether use of an ultra-high sensitivity camera with enhanced imaging technology can be used during surgery to detect areas of brain tissue affected by diffuse glioma, a type of brain cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- Intra-operative imaging of 5-ALA fluorescence using ultra-high sensitivity camera, Intra-operative imaging of 5-ALA fluorescence using in-built operative microscope camera and Biopsies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Sep 2020to 3 Nov 2021
- Phase
- Interventional
- 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
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Female patients are not pregnant at time of surgery.
- Patient has consented to craniotomy for suspected glioma of any type with 5-ALA infusion.
Who cannot join
- Participants are participating in another trial at time of operation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
About this study
Official title: Improving Fluorescence-guided Brain Tumour Surgery With Ultra-high Sensitivity Imaging
The purpose of this study is to determine whether use of an ultra-high sensitivity camera with enhanced imaging technology can be used during surgery to detect areas of brain tissue affected by diffuse glioma, a type of brain cancer.
- Conditions
- Glioma
- Being tested
- Intra-operative imaging of 5-ALA fluorescence using ultra-high sensitivity camera, Intra-operative imaging of 5-ALA fluorescence using in-built operative microscope camera, Biopsies
- Keywords
- 5-Aminolevulinic acid (5-ALA), Malignant glioma, Tumor resection
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-operative imaging of 5-ALA fluorescence using ultra-high sensitivity cameraDiagnostic test
An ultra-high sensitivity camera attached to the side arm of the operative microscope will be used to take images of the anterior, posterior, lateral and inferior walls of the resection cavity on completion of tumour resection.
Intra-operative imaging of 5-ALA fluorescence using in-built operative microscope cameraDiagnostic test
In-built camera of the operative microscope will be used to take images of the anterior, posterior, lateral and inferior walls of the resection cavity on completion of tumour resection.
BiopsiesDiagnostic test
Following image capture, biopsies (approx 5x5x5mm size) will be taken from regions of the anterior, posterior, lateral and inferior walls of the resection cavity corresponding to the imaged areas.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative imaging of 5-ALA during tumour resection | Experimental | Participants will undergo 5-ALA guided tumour resection via craniotomy with the aim of achieving maximal safe tumour resection without significant neurological deficit. On completion of tumour resection, digital images will be taken of the resection cavity under blue light using (i) an in-built camera in the operative microscope and (ii) an ultra-high sensitivity camera attached to the side arm of the operative microscope. Biopsies approximately 5x5x5mm in size will then be taken from the anterior, posterior, lateral and inferior areas of the resection cavity which were imaged. These biopsies will be analysed by histopathology to determine the presence of glioma cells. Receives: Diagnostic Test: Intra-operative imaging of 5-ALA fluorescence using ultra-high sensitivity camera; Diagnostic Test: Intra-operative imaging of 5-ALA fluorescence using in-built operative microscope camera; Diagnostic Test: Biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of tumour fluorescence in images of resection cavity captured during surgery
Levels of tumour fluorescence in intra-operative images of the resection cavity taken by the ultra-high sensitivity camera and the in-built camera in the operative microscope will be measured. These fluorescence levels will then be used to calculate the sensitivity and specificity of the in-built camera and ultra-high sensitivity camera to detect glioma tissue.
Measured: Intra-operative
Secondary outcomes (1)
Duration of operation stages
Time points measured will include (i) time from arrival in theatre to start of operation, (ii) total operation duration and (iii) time from acquisition of images to availability of processed images available for the surgeon to view.
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start21 Sep 2020
- Primary completion3 Nov 2021
- Study completion3 Nov 2021
Why it stopped: Technical limitations of in-built operative microscope optics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Puneet Plaha, MD FRCS, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556929
- Sponsor's protocol ID
- 255263
- Acronym
- EDGE
- Status last verified
- Sep 2020
- First submitted
- 30 Jul 2020
- Last updated
- 22 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Fluorescence-guided Brain Tumour Surgery With Ultra-high Sensitivity Imaging
- ClinicalTrials.gov ID
- NCT04556929
- Acronym / sponsor ID
- EDGE / 255263
- Conditions
- Glioma
- Keywords
- 5-Aminolevulinic acid (5-ALA), Malignant glioma, Tumor resection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Technical limitations of in-built operative microscope optics
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 3 Nov 2021 (actual)
- First posted
- 21 Sep 2020 (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 determine whether use of an ultra-high sensitivity camera with enhanced imaging technology can be used during surgery to detect areas of brain tissue affected by diffuse glioma, a type of brain cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative imaging of 5-ALA during tumour resection | Experimental | Diagnostic Test: Intra-operative imaging of 5-ALA fluorescence using ultra-high sensitivity camera, Diagnostic Test: Intra-operative imaging of 5-ALA fluorescence using in-built operative microscope camera, Diagnostic Test: BiopsiesParticipants will undergo 5-ALA guided tumour resection via craniotomy with the aim of achieving maximal safe tumour resection without significant neurological deficit. On completion of tumour resection, digital images will be taken of the resection cavity under blue light using (i) an in-built camera in the operative microscope and (ii) an ultra-high sensitivity camera attached to the side arm of the operative microscope. Biopsies approximately 5x5x5mm in size will then be taken from the anterior, posterior, lateral and inferior areas of the resection cavity which were imaged. These biopsies will be analysed by histopathology to determine the presence of glioma cells. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Female patients are not pregnant at time of surgery.
- Patient has consented to craniotomy for suspected glioma of any type with 5-ALA infusion.
Key exclusion criteria (1 listed)
- Participants are participating in another trial at time of operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-operative imaging of 5-ALA fluorescence using ultra-high sensitivity cameraAn ultra-high sensitivity camera attached to the side arm of the operative microscope will be used to take images of the anterior, posterior, lateral and inferior walls of the resection cavity on completion of tumour resection. | Diagnostic test | Intraoperative imaging of 5-ALA during tumour resection |
| Intra-operative imaging of 5-ALA fluorescence using in-built operative microscope cameraIn-built camera of the operative microscope will be used to take images of the anterior, posterior, lateral and inferior walls of the resection cavity on completion of tumour resection. | Diagnostic test | Intraoperative imaging of 5-ALA during tumour resection |
| BiopsiesFollowing image capture, biopsies (approx 5x5x5mm size) will be taken from regions of the anterior, posterior, lateral and inferior walls of the resection cavity corresponding to the imaged areas. | Diagnostic test | Intraoperative imaging of 5-ALA during tumour resection |
Primary outcome
Level of tumour fluorescence in images of resection cavity captured during surgery
Time frame: Intra-operative
Levels of tumour fluorescence in intra-operative images of the resection cavity taken by the ultra-high sensitivity camera and the in-built camera in the operative microscope will be measured. These fluorescence levels will then be used to calculate the sensitivity and specificity of the in-built camera and ultra-high sensitivity camera to detect glioma tissue.
1 secondary outcome
Duration of operation stages
Time frame: Intra-operative
Results and safety
The study was stopped early (reason given: Technical limitations of in-built operative microscope optics). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: Yes
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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.
Puneet Plaha, MD FRCS principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-operative imaging of 5-ALA fluorescence using ultra-high sensitivity camera, Intra-operative imaging of 5-ALA fluorescence using in-built operative microscope camera and Biopsies in people with Glioma, run by University of Oxford 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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 22 Mar 2024. 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?
The study was stopped early (reason given: Technical limitations of in-built operative microscope optics). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of tumour fluorescence in images of resection cavity captured during surgery (time frame: Intra-operative). 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 22 Mar 2024.