Gynaecologic Organ Segmentation and Motion Tracking Using Ultrasound (GENIUS)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Radiotherapy is an established and effective method for treating cancer, but it can have negative side effects if healthy tissues are also exposed to radiation. In the case of cervical cancer, the bladder, small bowel, and bone marrow are often irradiated, which can result in both short-term and long-term side effects. There are sophisticated radiation delivery techniques (known as IMRT and VMAT) which are capable of administering the radiation dose in a precise and controlled manner so that the intended target is irradiated and the healthy tissue is spared. However, the only way for these sophisticated radiation delivery methods to work in cervical cancer is to localise the uterus prior to radiotherapy treatment so that the lineup between the radiation beam and the target is ensured. The uterus is a relatively mobile organ, and can have very different positions within the body depending on the patient position, bladder volume, tumour site, etc. Currently, we are unable to take advantage of the sophisticated radiation delivery techniques as we have no reliable way of seeing where the uterus is. Ultrasound is a promising way to overcome this problem.
Ultrasound is non-ionising, has good soft-tissue contrast, and can easily be incorporated into the radiation treatment room. We wish to establish the feasibility and accuracy of localising and outlining the uterus on ultrasound images. This will enable us to determine whether or not ultrasound will be a good option to ensure the correct patient position prior to radiotherapy for cervical cancer patients.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Surrey
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Sutton, Surrey, Reino Unido, SM2 5PT
- Reclutamiento
- Royal Marsden Hospital NHS Foundation Trust
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Contacto:
- Julie Curtis
- Número de teléfono: 02086713873
- Correo electrónico: julie.curtis@rmh.nhs.uk
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Sub-Investigador:
- Sarah Mason
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- healthy volunteer cohort: Healthy female adult volunteers
- patient volunteer cohort: Patients receiving radiotherapy for cervical cancer who will receive a planning CT scan and daily CBCT scanning as part of their treatment.
Exclusion Criteria:
- both cohorts: Women who have received hysterectomies and women who are pregnant at the time of the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
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Healthy volunteers
Healthy female adult volunteers
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Cervical cancer patients
Patients receiving radiotherapy for cervical cancer at the Royal Marsden who will receive a planning CT scan and daily CBCT scanning as part of their treatment.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of ultrasound scans with dice similarity coefficient (DSC) of >0.90 between algorithm-derived contour and ground-truth contour
Periodo de tiempo: DSC calculated at 24 time points for each healthy volunteer (3 days)
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The DSC between the ground truth contour and the algorithm derived contour will indicate the accuracy of the segmentation algorithm.
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DSC calculated at 24 time points for each healthy volunteer (3 days)
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Coefficient of variation between of expert-drawn contours on ultrasound and expert-drawn contours on CBCT
Periodo de tiempo: COV calculated at a minimum of 3 time points during 6 weeks that the patient is receiving radiation therapy
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A small COV will indicate greater clinician/expert confidence in segmenting the uterus
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COV calculated at a minimum of 3 time points during 6 weeks that the patient is receiving radiation therapy
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Bland-Altman plot (healthy volunteer cohort)
Periodo de tiempo: 1 day
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Used to describe the level of agreement between MR and ultrasound images of the uterus.
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1 day
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Uterine center of mass displacement on ultrasound (healthy volunteer cohort)
Periodo de tiempo: 3 days
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Assess both inter- and intra- fractional motion of the uterus.
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3 days
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Expert confidence scores for each imaging modality (ultrasound and MR) (healthy volunteer cohort)
Periodo de tiempo: from data collected over 3 days
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Determine if uterine segmentation on ultrasound receives acceptable confidence score compared with MR
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from data collected over 3 days
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Bland-Altman plot (patient volunteer cohort)
Periodo de tiempo: 6 weeks
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describe level of agreement among the COV, circularity index, volume, and centre of mass position betweeen ultrasound, CT, and CBCT.
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6 weeks
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Expert confidence scores for each imaging modality (ultrasound, CT, and CBCT) (patient volunteer cohort)
Periodo de tiempo: from data collected over 6 weeks
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Determine if uterine segmentation on ultrasound receives greater confidence score compared with CT and CBCT.
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from data collected over 6 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Susan Lalondrelle, Royal Marsden Hospital NHS Foundation Trust
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- CCR4342
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