ClinicalTrials.gg
Not yet recruitingNCT07670455BRIGHTERUpdated Jun 30, 2026

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

An interventional study of Oxygen-Enhanced MRI (OE-MRI) in High Grade Gliomas, Hypoxia Brain and Glioblastoma (GBM), sponsored by The Leeds Teaching Hospitals NHS Trust. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by The Leeds Teaching Hospitals NHS Trust · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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. 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. 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.
02

Conditions studied

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

Keywords

  • Oxygen-enhanced MRI
  • OE-MRI
  • Functional MRI
  • Hypoxia imaging
  • Quantitative MRI
  • Tumour hypoxia
03

In context

Hypoxia, Brain

81 studies on the registry are indexed under Hypoxia, Brain; 19 are open to participants now.

This study's planned enrollment of 25 is below the median of 60 across 55 interventional studies indexed under Hypoxia, Brain.

Browse Hypoxia, Brain studies →

Lead sponsor

The Leeds Teaching Hospitals NHS Trust is the lead sponsor of 101 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Participants with any MRI 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    OE-MRI in high-grade glioma

    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

  • Diagnostic testOxygen-Enhanced MRI (OE-MRI)

    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.

06

What researchers measure

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.

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Aug 2028, 23 months later.

Of 33 non-industry interventional studies with no phase under Hypoxia, Brain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 44. This study's planned 23 months is above that.

Counting every sponsor, half of 33 studies reached it within 20 months; a quarter within 7 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 19, 2026
First posted
Jun 26, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Aug 31, 2028
CompletionEst.
Oct 31, 2028
Last update
Jun 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07670455
Responsible party
Sponsor
First posted
Jun 26, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Aug 31, 2028 (estimated)
Completion
Oct 31, 2028 (estimated)
Last update
Jun 30, 2026

Study contacts

Christopher J. H. Pagett, MSc, MPhys
Contact
christopher.pagett@nhs.net
+441132067969

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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