Brain TumorPEAR-GLIONCT06038760
Prospective Evaluation of AI R&D Tool in Adult Glioma and Other Primary Brain Tumours (PEAR-GLIO)
An observational study of Brain Tumor and Glioma, Malignant, run by Ourotech, Inc. at 1 site in United Kingdom.
Trial summary
Pear Bio has developed a 3D microtumor assay and computer vision pipeline through which the response of an individual patient's tumor to different anti-cancer regimens can be tested simultaneously ex vivo. This study will recruit patients with primary brain tumors who are due to undergo surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor, Glioma, Malignant, Ependymoma
- What is being tested?
- Resection
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Oct 2023to 25 Jul 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 with primary solid brain tumor
Who may be able to join
- Patient diagnosed with operable brain cancer, thought likely to be primary solid brain tumor on imaging (grade 2 - 3 meningioma; grade 1 - 4 tumors otherwise) or with histologically proven primary malignant solid brain tumor
- Able to give written informed consent prior to admission to this study;
- Female or male aged ≥18 years;
- Patient consents to the use of their surgical sample and 40mL of whole blood for research purposes
- Surgical sample and yields ≥0.4g for the study
- Patient consents to providing histopathology data (e.g., confirmation of histological subtype as oligodendroglioma) and other pseudonymised health information including imaging, treatment and outcome data.
Who cannot join
- Inoperable or biopsy only
- Suspected lymphoma or myeloma, or grade 1 meningioma
- Preoperative haemoglobin levels below 120g/L
- Patients who have already received chemotherapy, targeted therapy, immunotherapy, or radiotherapy less than 30 days before date of surgery, unless as part of a clinical trial (requires per-patient sponsor approval)
- Recurrence of cancer originating from a site other than the brain
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Healthcare NHS Trust
London, W6 8RF
About this study
Pear Bio has developed a 3D microtumor assay and computer vision pipeline through which the response of an individual patient's tumor to different anti-cancer regimens can be tested simultaneously ex vivo. This study will recruit patients with primary brain tumors who are due to undergo surgery.
Oncologists will be blinded to treatment response on the Pear Bio tool (the assay will be run in parallel with the patient's treatment). The primary objective of this study is to establish the ex vivo model and confirm whether approved therapies exhibit their intended mechanism of action in the model. Secondary objectives include correlating test results to patient outcomes, where available.
Read the detailed description
This is a multicenter, observational pilot study that aims to determine the feasibility of using the Pear Bio tool in patients with primary solid brain tumors.
Patients who are due to undergo clinically-mandated surgery will provide informed consent to donate excess tissue and a 40mL blood sample.
The samples will be tested on the Pear Bio tool while the patient receives their standard of care treatment. As such, for this study, the result from the Pear Bio tool will not be used to inform the choice of treatment and the treating oncologist will be blinded to the assay results.
The investigators will examine drug mechanism of action (MoA), differentiated response, and correlate that with outcomes seen in the patients treated in routine clinical practice.
- Conditions
- Brain Tumor, Glioma, Malignant, Ependymoma, Oligodendroglioma, Glioblastoma
- Being tested
- Resection
- Keywords
- computer vision, cell culture, microtumor, functional testing, predictive biomarker, precision medicine, oncology, brain cancer
- Medical subject headings
- Brain Neoplasms, Glioma, Ependymoma, Oligodendroglioma, Glioblastoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResectionProcedure or surgery
Patients undergo a resection from a lesion, and give 40mL of blood
| Study group | Role | What they receive |
|---|---|---|
| Trial Cohort | Patients with a solid primary brain tumor due to undergo surgery as standard of care Receives: Procedure: Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differentiated ex vivo treatment response
Measurement of treatment response in the Pear Assay
Measured: 2 weeks
Secondary outcomes (1)
Progression-free survival correlation
The correlation between response in the Pear Bio system and PFS in patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start12 Oct 2023
- Primary completion1 Dec 2024
- Study completion25 Jul 2025
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ourotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Imperial College Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Matt Williams, FRCR PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038760
- Sponsor's protocol ID
- PEAR-GLIO
- Acronym
- PEAR-GLIO
- Status last verified
- Jul 2025
- First submitted
- 8 Sep 2023
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pseudonymised data will be shared between study sites, such as treatment and outcome data for each patient. No publication will be made revealing individual patient data; only group-level data will be published.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of AI R&D Tool in Adult Glioma and Other Primary Brain Tumours (PEAR-GLIO)
- ClinicalTrials.gov ID
- NCT06038760
- Acronym / sponsor ID
- PEAR-GLIO / PEAR-GLIO
- Conditions
- Brain Tumor, Glioma, Malignant, Ependymoma, Oligodendroglioma, Glioblastoma
- Keywords
- computer vision, cell culture, microtumor, functional testing, predictive biomarker, precision medicine, oncology, brain cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ourotech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Imperial College Healthcare NHS Trust
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 15 Sep 2023 (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.
Pear Bio has developed a 3D microtumor assay and computer vision pipeline through which the response of an individual patient's tumor to different anti-cancer regimens can be tested simultaneously ex vivo. This study will recruit patients with primary brain tumors who are due to undergo surgery.
Oncologists will be blinded to treatment response on the Pear Bio tool (the assay will be run in parallel with the patient's treatment). The primary objective of this study is to establish the ex vivo model and confirm whether approved therapies exhibit their intended mechanism of action in the model. Secondary objectives include correlating test results to patient outcomes, where available.
Detailed description
This is a multicenter, observational pilot study that aims to determine the feasibility of using the Pear Bio tool in patients with primary solid brain tumors.
Patients who are due to undergo clinically-mandated surgery will provide informed consent to donate excess tissue and a 40mL blood sample.
The samples will be tested on the Pear Bio tool while the patient receives their standard of care treatment. As such, for this study, the result from the Pear Bio tool will not be used to inform the choice of treatment and the treating oncologist will be blinded to the assay results.
The investigators will examine drug mechanism of action (MoA), differentiated response, and correlate that with outcomes seen in the patients treated in routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trial Cohort | – | Procedure: ResectionPatients with a solid primary brain tumor due to undergo surgery as standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary solid brain tumor
Key inclusion criteria (6 listed)
- Patient diagnosed with operable brain cancer, thought likely to be primary solid brain tumor on imaging (grade 2 - 3 meningioma; grade 1 - 4 tumors otherwise) or with histologically proven primary malignant solid brain tumor
- Able to give written informed consent prior to admission to this study;
- Female or male aged ≥18 years;
- Patient consents to the use of their surgical sample and 40mL of whole blood for research purposes
- Surgical sample and yields ≥0.4g for the study
Key exclusion criteria (6 listed)
- Inoperable or biopsy only
- Suspected lymphoma or myeloma, or grade 1 meningioma
- Preoperative haemoglobin levels below 120g/L
- Patients who have already received chemotherapy, targeted therapy, immunotherapy, or radiotherapy less than 30 days before date of surgery, unless as part of a clinical trial (requires per-patient sponsor approval)
- Recurrence of cancer originating from a site other than the brain
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 |
|---|---|---|
| ResectionPatients undergo a resection from a lesion, and give 40mL of blood | Procedure or surgery | Trial Cohort |
Primary outcome
Differentiated ex vivo treatment response
Time frame: 2 weeks
Measurement of treatment response in the Pear Assay
1 secondary outcome
Progression-free survival correlation
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No. Pseudonymised data will be shared between study sites, such as treatment and outcome data for each patient. No publication will be made revealing individual patient data; only group-level data will be published.
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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.
Matt Williams, FRCR PhD principal investigator
Imperial College London
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 Brain Tumor and Glioma, Malignant, run by Ourotech, Inc. 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 6 inclusion and 6 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 30 Jul 2025. 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: Lack of funding). 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?
Differentiated ex vivo treatment response (time frame: 2 weeks). 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 30 Jul 2025.