Brain Radiotherapy Imaging for High-grade Glioma Using Hypoxia Targeting Through Oxygen-Enhanced Response

NCT07670455 | Not Yet Recruiting

• 4 other identifiers: 26/YH/0136NIHR30604534963064862 (BRIGHTER)
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

High-grade gliomas (HGGs) are the most common type of brain cancer in adults. Life expectancy for patients with HGGs is low. Radiotherapy aims to cure the tumour, but this is hard because HGGs are resistant to treatment. Among the possible causes of resistance may be tumour cells with low-oxygen levels (hypoxia). The investigators know that hypoxia reduces tumour sensitivity to radiotherapy. Using a special imaging technique called oxygen-enhanced MRI (OE-MRI), the investigators can try to identify areas of the tumour with hypoxia. The investigators could then give those areas a higher dose of radiotherapy. This might improve tumour control. This study aims to see if OE-MRI can find low-oxygen areas in HGGs. The study will also assess whether higher radiotherapy doses can be simulated in these regions. Project summary:

1. 1.Set up the OE-MRI process at Leeds Cancer Centre (LCC). OE-MRI settings will be tested on healthy volunteer participants to ensure the images are as good as possible.
2. 2.Participant Imaging. Patient participants with HGG will be recruited to take part. OE-MRI will be used to image participants during their treatment and track low-oxygen areas before treatment, halfway through treatment and 3 months after treatment has finished.
3. 3.Dose Escalation Assessment. Computer programs will be used to design radiotherapy treatments to test if higher radiation doses to the tumour's low-oxygen areas can better control the cancer. This will help understand if this targeted approach has potential benefits. This is modelling and will not alter routine clinical patient participant management.

Conditions

High Grade Gliomas; Hypoxia Brain; Glioblastoma (GBM); Brain Neoplasms, Adult

Keywords

Oxygen-enhanced MRI; OE-MRI; Functional MRI; Hypoxia imaging; Quantitative MRI; Tumour hypoxia

Outcome Measures

Primary Outcomes (1)

• Quantification of tumour hypoxia using oxygen-enhanced MRI (OE-MRI)

  This study aims to determine whether a special MRI- oxygen-enhanced magnetic resonance imaging (OE-MRI)- can effectively show regions of low oxygen in patients with aggressive brain tumours (high-grade glioma (HGG)), and whether this information can help doctors target radiotherapy more accurately and improve patient outcomes.

  From enrolment to the 3 month post-radiotherapy follow-up imaging

Study Arms (1)

OE-MRI in high-grade glioma

EXPERIMENTAL

Participants with high-grade glioma undergo oxygen-enhanced MRI (OE-MRI) at multiple time points (pre-treatment, mid-radiotherapy, and post-treatment) to assess tumour hypoxia. Oxygen is administered as a physiological stimulus during imaging. Data are used to evaluate hypoxia and to perform radiotherapy dose escalation modelling. No changes to standard clinical care are made.

Diagnostic Test: Oxygen-Enhanced MRI (OE-MRI)

Interventions

Oxygen-Enhanced MRI (OE-MRI) DIAGNOSTIC_TEST

Oxygen-enhanced magnetic resonance imaging (OE-MRI) is performed to assess tumour hypoxia. Participants undergo MRI scanning while breathing oxygen administered as a physiological stimulus to generate contrast related to tissue oxygenation. Imaging is conducted at multiple time points during standard treatment. The procedure is used for assessment only and does not alter clinical management.

OE-MRI in high-grade glioma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18yrs.
• Participants able to communicate with staff and safely comply with the study procedures.
• Participants to provide informed written consent.

You may not qualify if:

• Participants with any MRI contraindications including inability to lie flat in MRI scanner, claustrophobia and no foreign bodies, medical devices or other items which are considered an MRI contraindication.
• Geographically remote patients unable to agree to imaging schedule.
• Participants with illness or condition which means they cannot understand the requirements of the study.
• Participants with cardiac or pulmonary disease that are unable to tolerate the flow of oxygen delivered via a mask.
• Participants who have previously been treated with bleomycin (a chemotherapy used to treat some cancers including Hodgkin lymphoma and germ cell tumours).
• Participants with contraindications to gadolinium-based contrast agent

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

MeSH Terms

Conditions

Hypoxia, Brain; Glioblastoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Astrocytoma; Glioma; 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

Central Study Contacts

Christopher J. H. Pagett, MSc, MPhys

CONTACT

+441132067969; christopher.pagett@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share