- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02503917
Gynaecologic Organ Segmentation and Motion Tracking Using Ultrasound (GENIUS)
Visão geral do estudo
Status
Condições
Descrição detalhada
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 estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
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Surrey
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Sutton, Surrey, Reino Unido, SM2 5PT
- Recrutamento
- Royal Marsden Hospital NHS Foundation Trust
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Contato:
- Julie Curtis
- Número de telefone: 02086713873
- E-mail: julie.curtis@rmh.nhs.uk
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Subinvestigador:
- Sarah Mason
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Percentage of ultrasound scans with dice similarity coefficient (DSC) of >0.90 between algorithm-derived contour and ground-truth contour
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Bland-Altman plot (healthy volunteer cohort)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CCR4342
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