Prospective Evaluation of AI R&D Tool in Adult Glioma and Other Primary Brain Tumours (PEAR-GLIO)

NCT06038760 | Terminated DMC

• 1 other identifier: PEAR-GLIO
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Brain Tumor; Glioma, Malignant; Ependymoma; Oligodendroglioma; Glioblastoma

Keywords

computer vision; cell culture; microtumor; functional testing; predictive biomarker; precision medicine; oncology; brain cancer

Outcome Measures

Primary Outcomes (1)

• Differentiated ex vivo treatment response

  Measurement of treatment response in the Pear Assay

  2 weeks

Secondary Outcomes (1)

• Progression-free survival correlation

  1 year

Other Outcomes (5)

• Culture success rate of tumor cells

  1 week

• Culture rates success for immune cells

  1 week

• Find correlations between ex vivo tumor culture or multi-omic biomarkers and real-world patient outcomes

  12 months

Study Arms (1)

Trial Cohort

Patients with a solid primary brain tumor due to undergo surgery as standard of care

Procedure: Resection

Interventions

Resection PROCEDURE

Patients undergo a resection from a lesion, and give 40mL of blood

Trial Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary solid brain tumor

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ourotech, Inc.: lead
• Imperial College Healthcare NHS Trust: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W6 8RF, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor resections and blood

MeSH Terms

Conditions

Brain Neoplasms; Glioma; Ependymoma; Oligodendroglioma; Glioblastoma; Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma

Study Officials

• Matt Williams, FRCR PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 15, 2023
• Study Start: October 12, 2023
• Primary Completion: December 1, 2024
• Study Completion: July 25, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)