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Avaliação da nova TC de feixe cônico para orientação e adaptação de radioterapia de precisão

4 de agosto de 2026 atualizado por: Varian, a Siemens Healthineers Company
Este é um estudo de viabilidade que investiga a qualidade da imagem de uma nova TC de feixe cônico (CBCT) de alto desempenho usada para imagens no sofá durante tratamentos de radioterapia.

Visão geral do estudo

Status

Concluído

Intervenção / Tratamento

Descrição detalhada

Este estudo enfoca os benefícios potenciais de um sistema de orientação de imagens de TC de feixe cônico (CBCT) de alto desempenho para melhorar a precisão na aplicação de radioterapia. Atualmente, a CBCT é usada durante a radioterapia para alinhar o paciente ao seu plano de tratamento original para aumentar a precisão da aplicação da radiação. A tecnologia de imagem CBCT atual requer aproximadamente um minuto para adquirir uma imagem. A fim de adquirir imagens com qualidade suficiente para permitir um direcionamento preciso, o paciente pode precisar realizar várias manobras de apneia para "congelar" o movimento dos tumores que se movem com o ciclo respiratório (por exemplo, tumores de pulmão, fígado e mama). O novo CBCT de alto desempenho pode adquirir uma imagem em aproximadamente 6 segundos, permitindo potencialmente a aquisição de imagens com uma única pausa na respiração. Algoritmos de compensação de movimento aprimorados usados ​​na reconstrução de imagens podem permitir a aquisição de imagens de boa qualidade mesmo quando o paciente não está prendendo a respiração.

A metodologia para a configuração do tratamento do sujeito, simulação de TC, planejamento do tratamento, orientação por imagem e aplicação do tratamento será determinada pela equipe de tratamento do sujeito e não é especificada por este estudo. A inscrição no estudo pode ocorrer após o início do tratamento, mas deve ser antes da quinta fração.

Após a conclusão do consentimento informado para participar deste estudo, imagens de CBCT de alto desempenho serão agendadas imediatamente antes ou depois de uma das cinco primeiras frações de tratamento de radiação programadas do sujeito. Duas imagens de CBCT de pesquisa serão adquiridas, uma com respiração suspensa e outra com respiração livre.

Com o mínimo de interrupção para os pacientes participantes, este estudo permitirá uma comparação de (i) planejamento de tratamento do sujeito CT fan-beam e (ii) o CBCT convencional adquirido em uma unidade de tratamento existente com (iii) o CBCT de alto desempenho. A qualidade de imagem dos dados de imagem CBCT de alto desempenho será, assim, comparada com um padrão de melhor caso (feixe de ventilador) e o status quo para imagens no sofá para isolar e identificar melhorias.

Tipo de estudo

Intervencional

Inscrição (Real)

31

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Nova Scotia
      • Halifax, Nova Scotia, Canadá, B3H 2E2
        • Nova Scotia Health (QEII)

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

19 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  • O sujeito está agendado para tratamento em uma das cinco plataformas TrueBeam no site NS Health QE2.
  • O sujeito está recebendo radioterapia usando uma técnica de apneia (por exemplo, câncer de pulmão, fígado e mama esquerda).

Critério de exclusão:

  • A paciente está grávida ou tem planos de engravidar durante o período de tratamento.
  • O paciente não está disposto a consentir em participar do estudo, ou para quem o consentimento informado não é possível.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Imagens de CBCT de alto desempenho
Dois conjuntos de imagens de estudo adicionais são adquiridos.
Duas imagens de CBCT de pesquisa serão adquiridas por assunto.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
CBCT Image Quality - Artifact Index
Prazo: 1 day

Artifact Index (AI) is a measurement of the strength of imaging artifact and the degree to which is affects visibility of anatomical structures in the vicinity of the artifact. Artifacts can be produced in CT and CBCT images by a number of factors, such as metal implants, gas, or breathing motion.

AI = sqrt((STD_VOI)^2 - (STD_background)^2),

where STD_VOI is the standard deviation of the image Hounsfield Units in a region of interest at the location of an artifact, and STD_background is the standard deviation of the Hounsfield Unit values in the background (i.e. in similar tissue but away from the artifact.

A lower AI value indicates that the artifact has a lower impact on image quality. Artifacts were identified in all study participants. The median AI across the study population is presented for four imaging modalities.

1 day
CBCT Image Quality - Image Nonuniformity
Prazo: 1 day

Nonuniformity (NU) is a measure of the variation of CT image intensity in uniform tissue.

NU = (HU_max - HU_min)/(HU_max + HU_min),

where HU_max and HU_min are the maximum and minimum Hounsfield Unit values among multiple locations sampled within regions of uniform tissue that were relevant to the anatomy of interest (e.g., a uniform region of breast tissue for patients undergoing breast treatments).

A lower NU represents greater uniformity of CT image intensity within a region of interest. Median NU across the study population is presented for four imaging modalities.

1 day
CBCT Image Quality - Contrast
Prazo: 1 week

Contrast represents the ability to distinguish between two different regions in a CT image (e.g. to distinguish between two adjacent organs).

Contrast = |HU1 - HU2|

where HU1 and HU2 are the mean HU values in two different 100 mm^2 ROIs, where the ROIs were located in two different tissue types that were relevant to the site being treated (e.g., in the liver and in perihepatic fat for liver treatments).

Higher contrast values indicate that it is easier to distinguish between regions (anatomical structures) in a CT image. Median contrast across the study population is presented for four imaging modalities.

1 week
CBCT Image Quality - Contrast to Noise Ratio
Prazo: 1 week

Contrast to Noise Ratio (CNR) measures the ability to distinguish an object or lesion from its background.

CNR = |HU1 - HU2|/[0.5 (STD1 + STD2)]

where HU1 and HU2 are the mean Hounsfield Unit values in two different 100 mm^2 ROIs, where the ROIs were located in two different tissue types that were relevant to the site being treated (e.g., in the liver and in perihepatic fat for liver treatments), and STD1 and STD2 are the standard deviations of the HU values in those same ROIs.

A higher CNR makes it easier to distinguish an object from its background. CNR analysis was limited to images with similar imaging dose. Median CNR across all study participants treated for lung cancer are presented for three CBCT modalities.

1 week
CBCT Image Quality - HU Similarity to CT Simulation
Prazo: 1 week

The intensity of a pixel in a CT image is a function of its Hounsfield Unit (HU) value. HU is also directly related to the underlying electron density, which means that the pixel value of a CT image can be used directly in the calculation of dose for a prescribed radiation treatment plan. CT simulation scanners produce images with high HU accuracy and are regularly used for radiation treatment planning. Here, we present the difference in HU between CT simulation images and different CBCT images.

ΔHU = HU_CBCT - HU_CTSim,

where HU_CBCT and HU_CTSim are mean values among HU averages at 4 reference points in a CBCT image and the corresponding CT simulation image, respectively.

The lower the ΔHU, the greater the HU accuracy of the CBCT image, and the greater the likelihood that CBCT imaging can be used for radiation treatment planning. Median ΔHU across the study population are presented for three different tissue types for three CBCT imaging modalities.

1 week

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Dosimetry Calculations - Gamma Pass Rate
Prazo: 1 day
Every trial participant had a radiation treatment plan calculated on their CT simulation image series. That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT. The overall difference between calculated radiation distributions was evaluated using three different gamma pass criteria: 3% dose difference / 3 mm distance to agreement, 2%/2mm, and 1%/1mm. The gamma pass rate is expressed as a percentage of data points that meet the pass criteria. A gamma pass rate of > 95% is typically considered acceptable for 3%/3mm. As the gamma pass criteria become stricter, the pass rates decrease. Gamma pass rates were calculated to compare the CT simulation-based dose calculation and the high performance CBCT-based dose calculation. Gamma pass rates were also calculated to compare the CT simulation-based dose calculation and the conventional CBCT-based dose calculation. The median gamma pass rates across the entire study population are presented.
1 day
Dosimetry Calculations - Target DVH Volume Metrics
Prazo: 1 day
Every trial participant had a radiation treatment plan calculated on their CT simulation image series. That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT. Dose-volume histograms (DVH) were calculated for individual target structures from all three dose distributions. Individual DVH metrics, such as V90(%) (the percentage of the structure volume receiving 90% of the prescribed radiation dose) were extracted for individual target structures from their DVH. The difference between a DVH metric derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported. The smaller the difference, the greater the accuracy of the CBCT-based dose calculation. Median target DVH metric differences across the study population are presented.
1 day
Dosimetry Calculations - Target DVH Dose Metrics
Prazo: 1 day
Every trial participant had a radiation treatment plan calculated on their CT simulation image series. That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT. Dose-volume histograms (DVH) were calculated for individual target structures from all three dose distributions. Individual DVH dose metrics, such as D95(%) (the minimum dose covering 95% of the structure, expressed as a % of the prescription dose) were extracted for individual target structures from their DVH. The difference between a DVH metric derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported. The smaller the difference, the greater the accuracy of the CBCT-based dose calculation. Median target DVH metric differences across the study population are presented.
1 day
Dosimetry Calculations - Breast OAR DVH Metrics
Prazo: 1 day
Every trial participant had a radiation treatment plan calculated on their CT simulation image series. That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT. Dose-volume histograms (DVH) were calculated for individual organs at risk (OAR) from all three dose distributions. The key organs at risk for patients being treated for breast cancer are the heart, ipsilateral lung, and contralateral breast. The differences between the D2%(%) (minimum dose received by the "hottest" 2% of the OAR, expressed as a % of the prescription dose) derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported. The smaller the difference, the greater the accuracy of the CBCT-based dose calculation. Median differences in OAR D2%(%) across study participants treated for breast cancer are presented.
1 day
Dosimetry Calculations - Lung OAR DVH Metrics
Prazo: 1 day
Every trial participant had a radiation treatment plan calculated on their CT simulation image series. That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT. Dose-volume histograms (DVH) were calculated for individual organs at risk (OAR) from all three dose distributions. The key organs at risk for patients being treated for lung cancer are the heart, esophagus and spinal cord. The differences between the D2%(%) (minimum dose received by the "hottest" 2% of the OAR, expressed as a % of the prescription dose) derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported. The smaller the difference, the greater the accuracy of the CBCT-based dose calculation. Median differences in OAR D2%(%) across study participants treated for lung cancer are presented.
1 day
Dosimetry Calculations - Abdomen OAR DVH Metrics
Prazo: 1 day
Every trial participant had a radiation treatment plan calculated on their CT simulation image series. That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT. Dose-volume histograms (DVH) were calculated for individual organs at risk (OAR) from all three dose distributions. The key organs at risk for patients being treated for abdominal cancer are the heart, bowel and kidneys. The differences between the D2%(%) (minimum dose received by the "hottest" 2% of the OAR, expressed as a % of the prescription dose) derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported. The smaller the difference, the greater the accuracy of the CBCT-based dose calculation. Median differences in OAR D2%(%) across study participants treated for abdominal cancer are presented.
1 day
Patient Experience - General Ease of Breath Hold
Prazo: 1 Day
Study participants were asked to respond to the statement, "I find it easy to hold my breath", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".
1 Day
Patient Experience - Ease of Breath Hold on TrueBeam
Prazo: 1 Day
Study participants were asked to respond to the statement, "It was easy for me to perform the breath holds that were needed for imaging on the TrueBeam radiation machine", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".
1 Day
Patient Experience - Ease of Breath Hold on Ethos
Prazo: 1 Day
Study participants were asked to respond to the statement, "It was easy for me to perform the breath holds needed for imaging on the Ethos radiation machine", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".
1 Day
Patient Experience - Relative Ease of Breath Hold Between Machines
Prazo: 1 Day
Study participants were asked to respond to the statement, "It was easier for me to perform the breath holds needed for imaging on one radiation machine compared to the other", on a 5-point scale, where 1 represents "TrueBeam much easier", 3 represents "Both machines equally easy", and 5 represents "Ethos much easier".
1 Day
Patient Experience - Overall TrueBeam Experience
Prazo: 1 Day
Study participants were asked to respond to the statement, "My overall experience during imaging on the TrueBeam was good", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".
1 Day
Patient Experience - Overall Ethos Experience
Prazo: 1 Day
Study participants were asked to respond to the statement, "My overall experience during imaging on the Ethos platform was good", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".
1 Day

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

20 de dezembro de 2022

Conclusão Primária (Real)

30 de julho de 2023

Conclusão do estudo (Real)

30 de julho de 2023

Datas de inscrição no estudo

Enviado pela primeira vez

16 de dezembro de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de dezembro de 2021

Primeira postagem (Real)

4 de janeiro de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

26 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

produto fabricado e exportado dos EUA

Sim

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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