- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07670455
Brain Radiotherapy Imaging for High-grade Glioma Using Hypoxia Targeting Through Oxygen-Enhanced Response (BRIGHTER)
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). We know this makes tumours less sensitive to radiotherapy. Using a special imaging technique called oxygen-enhanced MRI (OE-MRI) we can try to identify areas of the tumour with hypoxia. We 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. It will also check if we can simulate higher doses of radiotherapy in these regions.
Project summary:
- Set up the OE-MRI process at Leeds Cancer Centre (LCC). OE-MRI settings will be tested on healthy volunteers to ensure the images are as good as possible.
- Patient Imaging. Patients with HGG will be recruited to take part. OE-MRI will be used to image patients during their treatment and track low-oxygen areas before treatment, halfway through treatment and 3 months after treatment has finished.
- 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 management.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christopher J. H. Pagett, MSc, MPhys
- Phone Number: +441132067969
- Email: christopher.pagett@nhs.net
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≥18yrs.
- Participants able to communicate with staff and safely comply with the study procedures.
- Participants to provide informed written consent.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantification of tumour hypoxia using oxygen-enhanced MRI (OE-MRI)
Time Frame: From enrolment to the 3 month post-radiotherapy follow-up imaging
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Signs and Symptoms, Respiratory
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Hypoxia
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Glioblastoma
- Brain Neoplasms
- Hypoxia, Brain
Other Study ID Numbers
- 26/YH/0136
- NIHR306045 (Other Grant/Funding Number: National Institute for Health and Care Research (NIHR), UK)
- 349630 (Other Identifier: Integrated Research Application System (IRAS), UK)
- 64862 (BRIGHTER) (Other Identifier: NIHR Clinical Research Network (Central Portfolio Management System, CPMS), UK)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Glioblastoma (GBM)
-
Peking University Third HospitalPeking University; Changping LaboratoryRecruitingGlioblastoma Multiforme (GBM) | Glioblastoma (GBM)China
-
Black Diamond Therapeutics, Inc.RecruitingCentral Nervous System Diseases | Glioma | Brain Cancer | GBM | Newly Diagnosed Glioblastoma | Glioblastoma Multiforme (GBM) | Glioblastoma (GBM)United States
-
NYU Langone HealthCompletedGBM | MGMT-unmethylated Glioblastoma (GBM)United States
-
Ever Supreme Bio Technology Co., Ltd.Recruiting
-
Northwell HealthCompletedGBM | Anaplastic Astrocytoma | Glioblastoma Multiforme (GBM) | ANAPLASTIC ASTROCYTOMA (AOA)United States
-
Insel Gruppe AG, University Hospital BernRecruiting
-
Trogenix ltdRecruitingRecurrent Glioblastoma | Newly Diagnosed Glioblastoma | Glioblastoma (GBM) | High Grade GliomasUnited Kingdom, United States
-
Beijing Tiantan HospitalRecruitingRecurrent Glioblastoma | Glioblastoma (GBM) | Recurrent Glioblastoma (WHO-Grade IV Glioma) | Recurrent Glioblastoma IDH WildtypeChina
-
CHA UniversityRecruitingGlioblastoma (GBM) | Newly Diagnosed Glioblastoma MultiformeSouth Korea
-
Xoft, Inc.Icad, Inc.TerminatedGlioblastoma | GBM | Recurrent Glioblastoma | Recurrent GBMUnited States
Clinical Trials on Oxygen-Enhanced MRI (OE-MRI)
-
Sean FainRecruitingChronic Lung Allograft Dysfunction Lung MRI (CLAD)United States
-
Nottingham University Hospitals NHS TrustCompletedHead and Neck Squamous Cell CarcinomaUnited Kingdom
-
Manchester University NHS Foundation TrustNot yet recruitingCoronary Artery DiseaseUnited Kingdom
-
Seoul National University Bundang HospitalBayerCompletedTraumaKorea, Republic of
-
University of Wisconsin, MadisonNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingCirrhosis, Liver | Gastroesophageal Varices | Fontan ProcedureUnited States
-
Northern Care Alliance NHS Foundation TrustRecruitingVestibular Schwannoma | Glioma, AstrocyticUnited Kingdom
-
Radboud University Medical CenterRecruitingHead and Neck Squamous Cell CarcinomaNetherlands
-
C.H. van GilsRadboud University Medical Center; University Medical Center Groningen; Maastricht... and other collaboratorsRecruitingBreast CancerNetherlands
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI); National Institute of Dental and Craniofacial...Recruiting
-
University of CincinnatiActive, not recruiting