- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02123888
Simultaneous CBCT Acquisition During Arc Radiotherapy (SCART)
Simultaneous Cone Beam Computed Tomography (CBCT) Acquisition During Arc Radiotherapy
The cone beam image is a part of the radiotherapy treatment machine and uses lower energy xrays as the head of the radiotherapy machine moves around the patient in a circle. This takes pictures that give 3-dimensional information, somewhat like a CT scan. These images are better at showing the position of the tumour and surrounding soft tissues than the standard xrays that were previously used. Cone Beam Imaging Technology is not new and has been used regularly at The Christie for many years. The standard cone beam scan is taken before the actual radiotherapy treatment or after the treatment has been delivered.
Volumetric Modulated Arc Therapy (VMAT or Arc Radiotherapy) is a novel method of delivering radiotherapy that involves the continuous movement of the radiotherapy treatment machine head around the patient and MLC during radiation. Arc radiotherapy has been clinically implemented at The Christie for prostate radiotherapy treatments and work is in progress for implementation in lung radiotherapy. The continuous gantry rotation inherent to VMAT delivery makes this simultaneous imaging possible, although there are concerns associated with the impact that this may have on patient dose and image quality.
The aim of this research is to assess whether the image quality of cone beam scans taken during treatment are as good as standard cone beam scans taken before or after treatment used to determine the accuracy of patient position and the tumour coverage by radiotherapy.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Greater Manchester
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Manchester, Greater Manchester, Reino Unido, M20 4BX
- Recrutamento
- The Christie NHS Foundation Trust
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Investigador principal:
- Corinne Faivre-Finn
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Subinvestigador:
- Ananya Choudhury
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Contato:
- Julie Stratford
- Número de telefone: 0044 (0)161 446 3506
- E-mail: julie.stratford@christie.nhs.uk
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria for prostate cancer patients:
- Patients to be treated with radical RT for prostate cancer
- Patients to be treated with VMAT
- ECOG performance status 0-2
- Patients must be able to receive and understand verbal and written information regarding the study and give written, informed consent
Inclusion Criteria for lung cancer patients:
- A histological or cytological diagnosis of non-small cell lung cancer or small cell lung cancer
- Patients to be treated with radical RT or SBRT
- Patients to be treated with VMAT
- ECOG performance status 0-2
- Patients must be able to receive and understand verbal and written information regarding the study and give written, informed consent
- Female patients must meet one of the following criteria - postmenopausal for a minimum of one year, surgically sterile, not pregnant, confirmed by β-HCG blood test and willing to use adequate contraception during study participation, not breastfeeding
Exclusion Criteria for prostate cancer patients:
- Clinical judgement by the investigator that the patient should not participate in the study
- Patients in clinical trials of new investigational medicinal products or treatment regimens unless there is written, prior agreement that the patient can also consent to this study, and that clinical data can also be used for this study
- Prior radiotherapy or surgery in the pelvis that can make identification of normal anatomy difficult
Exclusion criteria for lung cancer patients:
- Clinical judgement by the investigator that the patient should not participate in the study
- Patients in clinical trials of new investigational medicinal products or treatment regimens unless there is written, prior agreement that the patient can also consent to this study, and that clinical data can also be used for this study
- Prior radiotherapy or surgery in the region of interest that can make identification of normal anatomy difficult
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Cone Beam Computed Tomography
Simultaneous Cone Beam Computed Tomography acquisition during arc radiotherapy.
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Simultaneous Cone Beam Computed Tomography acquisition during arc radiotherapy
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Equivalence of image quality
Prazo: 12 months
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To show equivalence of image quality from simultaneous CBCT acquisition during delivery of arc radiotherapy with that obtained from conventional CBCT acquisition in lung and prostate patients, as assessed by user-questionnaires.
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12 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Quantify inter-observer variation
Prazo: 12 months
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To quantify inter-observer variation in interpretation of anatomy, as assessed by questionaires.
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12 months
|
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Quantify inter-observer variation
Prazo: 12 months
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To quantify inter-observer variation in delineation of specific structures on CBCT scans.
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12 months
|
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Quantify impact on treatment times.
Prazo: 12 months
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To quantify the impact of simultaneous CBCT scans on treatment times.
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12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ananya Choudhury, The Christie 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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 10_RADIO_94
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