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

Sponsor

Ourotech, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06038760

Collaborator

Imperial College Healthcare NHS Trust (Other)

Enrollment

Location

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Tumor Glioma, Malignant Ependymoma Oligodendroglioma Glioblastoma	Procedure: Resection

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

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Trial Cohort Patients with a solid primary brain tumor due to undergo surgery as standard of care	Procedure: Resection Patients undergo a resection from a lesion, and give 40mL of blood

Arm

Intervention/Treatment

Trial Cohort

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

Procedure: Resection

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

Outcome Measures

Primary Outcome Measures

Differentiated ex vivo treatment response [2 weeks]
Measurement of treatment response in the Pear Assay

Secondary Outcome Measures

Progression-free survival correlation [1 year]
The correlation between response in the Pear Bio system and PFS in patients

Other Outcome Measures

Culture success rate of tumor cells [1 week]
The percentage of cultures in which ≥70% of viable tumor cells encapsulated post-isolation on day 0 are still alive on day 3 in the control cultures (no treatment) compared to the number of tumor samples successfully accepted at the study central lab.
Culture rates success for immune cells [1 week]
The percentage of cultures in which ≥70% of viable immune cells plated post-extraction on day 0 are still alive on day 3 in the control cultures (no treatment) compared to the number of blood samples successfully accepted at the study central lab.
Find correlations between ex vivo tumor culture or multi-omic biomarkers and real-world patient outcomes [12 months]
To correlate Pear assay results, biomarkers and outcomes
Assess Pear Bio's assay ability to categorise patients for below average or above average overall survival (OS [12 months]
Categorisation of patients into survival cohorts using the Pear assay
Assess the correlation of omics biomarkers to patient PFS, ORR and/or OS [12 months]
Correlation between biomarkers and clinically relevant outcomes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion:

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.

Exclusion:

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.