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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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). 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:
- 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.
- 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.
- 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Christopher J. H. Pagett, MSc, MPhys
- Número de teléfono: +441132067969
- Correo electrónico: christopher.pagett@nhs.net
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Quantification of tumour hypoxia using oxygen-enhanced MRI (OE-MRI)
Periodo de tiempo: From enrolment to the 3 month post-radiotherapy follow-up imaging
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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.
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From enrolment to the 3 month post-radiotherapy follow-up imaging
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Neoplasias por sitio
- Neoplasias
- Neoplasias por tipo histológico
- Neoplasias Glandulares y Epiteliales
- Signos y Síntomas Respiratorios
- Astrocitoma
- Glioma
- Neoplasias Neuroepiteliales
- Tumores neuroectodérmicos
- Neoplasias De Células Germinales Y Embrionarias
- Neoplasias De Tejido Nervioso
- Neoplasias del Sistema Nervioso
- Neoplasias del Sistema Nervioso Central
- Hipoxia
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Glioblastoma
- Neoplasias Cerebrales
- Hipoxia, Cerebro
Otros números de identificación del estudio
- 26/YH/0136
- NIHR306045 (Otro número de subvención/financiamiento: National Institute for Health and Care Research (NIHR), UK)
- 349630 (Otro identificador: Integrated Research Application System (IRAS), UK)
- 64862 (BRIGHTER) (Otro identificador: NIHR Clinical Research Network (Central Portfolio Management System, CPMS), UK)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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