Evaluating an AI tool for brain tumor treatment response

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

This study is testing a new 3D lab tool to see how different treatments work on individual brain tumors from patients who are having surgery.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ourotech, Inc. (industry)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (London)
• Trial ID: NCT06038760 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the feasibility of a 3D microtumor assay developed by Pear Bio, which tests how individual brain tumors respond to various anti-cancer treatments ex vivo. Patients with primary brain tumors scheduled for surgery will donate excess tissue and blood samples, which will be analyzed while they receive standard care. The study will not inform treatment decisions but will focus on understanding drug mechanisms and correlating assay results with patient outcomes. The oncologists involved will remain blinded to the assay results to ensure unbiased treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with operable primary solid brain tumors.

Not a fit: Patients with inoperable tumors or those who have received recent chemotherapy or radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more personalized and effective treatment strategies for patients with brain tumors.

How similar studies have performed: While the use of AI and microtumor assays is a novel approach, similar studies have shown promise in other cancer types, indicating potential for success in this context.

Eligibility criteria

Inclusion:

1. 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
2. Able to give written informed consent prior to admission to this study;
3. Female or male aged ≥18 years;
4. Patient consents to the use of their surgical sample and 40mL of whole blood for research purposes
5. Surgical sample and yields ≥0.4g for the study
6. 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.

Exclusion:

1. Inoperable or biopsy only
2. Suspected lymphoma or myeloma, or grade 1 meningioma
3. Preoperative haemoglobin levels below 120g/L
4. 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)
5. Recurrence of cancer originating from a site other than the brain
6. 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.

Where this trial is running

London

• Imperial College Healthcare NHS Trust — London, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Matt Williams, FRCR PhD — Imperial College London
• Study coordinator: Duleek Ranatunga

Conditions: Brain Tumor, Glioma, Malignant, Ependymoma, Oligodendroglioma, Glioblastoma, computer vision, cell culture, microtumor