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

• ClinicalTrials.gov Identifier: NCT06038760
• Recruitment Status: Recruiting
• First Posted: September 15, 2023
• Last Update Posted: December 27, 2023
• Sponsor: Ourotech, Inc.
• Collaborator: Imperial College Healthcare NHS Trust
• Information provided by (Responsible Party): Ourotech, Inc.

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
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
• Estimated 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)
• Actual Study Start Date: October 12, 2023
• Estimated Primary Completion Date: December 1, 2024
• Estimated Study Completion Date: December 1, 2025

Groups and Cohorts

Group/Cohort	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 :

1. Differentiated ex vivo treatment response [ Time Frame: 2 weeks ]
   Measurement of treatment response in the Pear Assay

Secondary Outcome Measures :

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

Other Outcome Measures:

1. Culture success rate of tumor cells [ Time Frame: 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.
2. Culture rates success for immune cells [ Time Frame: 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.
3. Find correlations between ex vivo tumor culture or multi-omic biomarkers and real-world patient outcomes [ Time Frame: 12 months ]
   To correlate Pear assay results, biomarkers and outcomes
4. Assess Pear Bio's assay ability to categorise patients for below average or above average overall survival (OS [ Time Frame: 12 months ]
   Categorisation of patients into survival cohorts using the Pear assay
5. Assess the correlation of omics biomarkers to patient PFS, ORR and/or OS [ Time Frame: 12 months ]
   Correlation between biomarkers and clinically relevant outcomes

Biospecimen Retention:   Samples With DNA

Tumor resections and blood

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary solid brain tumor

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.

Contacts and Locations

Contacts

Contact: Duleek Ranatunga; +44 7716558079; duleek@pearbio.com

Contact: Elli Tham; elli.tham@pearbio.com

Locations

United Kingdom

Imperial College Healthcare NHS Trust; Recruiting

London, United Kingdom, W6 8RF

Contact: Waqar Saleem, MRCP FRCR 020 3311 8427

Sponsors and Collaborators

Ourotech, Inc.

Imperial College Healthcare NHS Trust

Investigators

• Principal Investigator: Matt Williams, FRCR PhD; Imperial College London

  Study Documents (Full-Text)

Documents provided by Ourotech, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] March 3, 2023

More Information

Study Data/Documents: Study Protocol 

• Responsible Party: Ourotech, Inc.
• ClinicalTrials.gov Identifier: NCT06038760
• Other Study ID Numbers: PEAR-GLIO
• First Posted: September 15, 2023
• Last Update Posted: December 27, 2023
• Last Verified: December 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ourotech, Inc.:

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

Additional relevant MeSH terms:

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