A Pilot Study Using Magnetic Resonance (MR) to Assess Cervix Motion During Radiotherapy Treatment. (MR Cervix)
The standard treatment for locally advanced cervical cancer is concurrent chemo-radiotherapy. This treatment is associated with long term side effects in around half of patients with up to 10% suffering from grade 3-4 toxicity.
The development of intensity modulated radiotherapy (IMRT) allows for shaping of radiotherapy fields to reduce the doses delivered to organs at risk (OARs). This does appear to reduce the risk of long and short term toxicity (although there is little randomized evidence). However pelvic organ position varies both between and even during radiotherapy fractions; this means that radiotherapy margins must be generous to allow adequate coverage of the clinical target volume (CTV) but this also increases dose to OARs.
There have been a number of studies evaluating pelvic organ motion in cervical cancer as well as assessing different adaptive radiotherapy strategies. These have included individualized margins, plan of the day and adaptive techniques. Most of these studies have been carried out using cone beam computed tomography (CBCT) imaging which is often poor quality with limited soft tissue contrast. MR offers better visualization of the tumour and OARs and is used for imaged guided brachytherapy treatment.
This study will explore the role of MR imaging in adaptive radiotherapy for cervical cancer with development of a number of theoretical treatment strategies.
Descripción general del estudio
Descripción detallada
Patients will undergo standard treatment during the study with five weeks of external beam radiotherapy (25 fractions) followed by a MR guided brachytherapy boost or external beam boost (further 10 fractions.) They will be treated with weekly cisplatin 40mg/m2 if clinically appropriate.
As part of standard treatment patients have a staging MR scan at diagnosis, a radiotherapy planning CT and an MR scan in the 4th week of treatment. Cone beam imaging will also be performed. Response will be assessed as standard with a MR scan at 3 months.
As part of the study patients will undergo 3 additional MR scans. These will take place in the 1st, 2nd and 5th weeks of treatment. Extra sequences will be added to the clinical mid-point scan in the 4th week of treatment. These MR scans will include anatomical images - with full and empty bladder as well as cine data (with a scan every minute for 10 minutes) to assess intra fraction motion. They will also include a DWI sequence, which will be used to assess if early prediction of response is possible. The frequency of cone beam imaging will be increased from approximately 10 scans as standard of care to 25 scans to allow for daily imaging.
The 1st MR scan will be contoured to outline clinical target volumes (CTVs) and OARs. A variety of planning strategies will be developed including standard planning target volume (PTV) margins, a plan of the day (POTD) approach, a POTD+ as well as an online adaptation model. These models will be used to assess coverage of CTV and PTV as well as dose to OARs using the scans obtained during the radiotherapy treatment. The practicality of each approach will also be assessed. Inter and intra fraction organ motion will also be analysed in order to develop patient specific models.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Greater Manchester
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Manchester, Greater Manchester, Reino Unido, M20 4BX
- The Christie NHS Foundation Trust
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Histologically confirmed diagnosis of cervical cancer
- Treatment with primary curative intent
- Undergoing external beam radiotherapy (+/-chemotherapy) followed by brachytherapy or an external beam boost
- Age over 18
Exclusion Criteria:
- Any contraindications to MR identified after MR safety screening including completion of an MR Safety Screening Form (see appendix 1)
- Previous hysterectomy
- Unable to tolerate MR scans
- Metastatic disease
- Pregnancy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- 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: MR scans
As part of the study patients will undergo 3 additional MR scans during radiotherapy treatment.
These will take place in the 1st, 2nd and 5th weeks of treatment.
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Additional imaging using MR scans.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Coverage of the Clinical Target Volume and dose to the Organs At Risk for different adaptive radiotherapy strategies.
Periodo de tiempo: 18 months
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Coverage of the Clinical Target Volume and dose to the Organs At Risk for different adaptive radiotherapy strategies.
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18 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Diffusion Weighted Imaging on MR prior to and during treatment and clinical response to treatment on post treatment MR scan.
Periodo de tiempo: 18 months
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Diffusion Weighted Imaging on MR prior to and during treatment and clinical response to treatment on post treatment MR scan.
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18 months
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Bladder filling using MR sequences and stratification of patients into large or small cervix motion.
Periodo de tiempo: 18 months
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Bladder filling using MR sequences and stratification of patients into large or small cervix motion.
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18 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Marcel van Herk, University of Manchester
- Investigador principal: Ananya Choudhury, The Christie NHS Foundation Trust
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- 17_RADIO_122
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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Ensayos clínicos sobre Cáncer de cuello uterino
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Stanford UniversityTerminadoCirugía Cervical Posterior | Fusión cervical posterior | Laminectomía cervical posterior | Laminoplastia Cervical PosteriorEstados Unidos
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University of ValenciaTerminadoLesión por latigazo cervical | Dolor de cuello crónico | Lesión por latigazo cervical de la columna cervical | Dolor Cervical PostraumáticoEspaña
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Assiut UniversityAún no reclutandoEstenosis cervical | Estenosis espinal cervical degenerativa
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Assiut UniversityAún no reclutandoEnfermedad degenerativa del disco cervical | Discectomía y fusión cervical anterior (ACDF) | Caja Cervical Con Tornillo
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NuVasiveInscripción por invitaciónRadiculopatía cervical | Enfermedad del disco cervical | Enfermedad de la columna cervical | Mielopatía cervical | Espondilosis cervical | Hernia de disco cervical | Estenosis cervicalEstados Unidos
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Gazi UniversityReclutamientoRadiculopatía cervical | Dolor radicular cervical | Radiculitis cervical | Síndrome de la raíz cervicalPavo
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Aalto UniversityUniversity of Minnesota; University of Mississippi Medical CenterAún no reclutandoMaduración Cervical | Inducción del Nacimiento | Maduración cervical e inducción del parto
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Blaz BarunTerminadoLesión por latigazo cervical de la columna cervicalCroacia
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University of IcelandLandspitali University Hospital; Reykjavik University; Empowered HealthActivo, no reclutandoLesión por latigazo cervical de la columna cervicalIslandia
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Valérie SchuermansReclutamientoEnfermedad del disco cervical | Fusión cervical | Fusión de columna | Espondilosis cervical | Hernia de disco cervical | Mielopatía cervical | Degeneración del disco cervical | Radiculopatía Cervical | Mielopatía Compresiva | Radiculopatía, Región Cervical | Radiculopatía; en espondilosis | Radiculopatía; en... y otras condicionesPaíses Bajos
Ensayos clínicos sobre MR scans
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Memorial Sloan Kettering Cancer CenterTerminadoCáncer de cerebroEstados Unidos
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Orion Corporation, Orion PharmaTerminado
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Second Affiliated Hospital of Nanchang UniversityReclutamientoProgreso de la miopíaPorcelana
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Johnson & Johnson Surgical Vision, Inc.Terminado
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Bezmialem Vakif UniversityMuğla Sıtkı Koçman University; The Scientific and Technological Research Council... y otros colaboradoresActivo, no reclutandoTrastornos de la alimentación | Comportamiento alimentario | Complicación del aparato de ortodoncia | Hábito alimenticioPavo
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Universitätsklinikum KölnGerman Federal Ministry of Education and ResearchReclutamientoSíndrome de la articulación facetariaAlemania
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University Hospital TuebingenReclutamientoCáncer de mama | Cáncer de cabeza y cuello | Cáncer de esófago | Cáncer de recto | Cancer de prostata | Cáncer de hígado | OligometástasisAlemania
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Philips HealthcareTerminadoFibras uterinasPorcelana
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Stanford UniversityRetiradoMetástasis óseasEstados Unidos
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Merck Healthcare KGaA, Darmstadt, Germany, an affiliate...Merck KGaA, Darmstadt, GermanyTerminado