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Investigating the Improvement in 4D CT Images Using AV Biofeedback (GCC0832)

16 de março de 2020 atualizado por: Department of Radiation Oncology, University of Maryland, Baltimore

Investigating the Improvement in 4D CT Images Using Audiovisual Biofeedback: An Intra-fraction and an Inter-fraction Evaluation.

This study will look at how tumors in the chest and abdomen move when you breathe. Your doctors are studying if extra 4D CT scans and instructions on how to breathe can help predict this type of movement and improve the accuracy of radiation treatment. 4D CT scans are approved by the FDA. A 4D CT scan is different from a regular CT because it moves slower and takes more pictures. It takes pictures of the way your body moves when you breathe. This gives doctors more pictures of your body so that they can match your pictures to the way you breathe.

In this study, instructions on how to breathe will be visual and audio. Visual instructions will be given to you on a computer screen. You will hear audio instructions through a speaker.

Visão geral do estudo

Status

Concluído

Descrição detalhada

JUSTIFICATION Among the various sites affected by cancer, statistics show that lung cancer is the leading cause of death among both men and women. One major reason for this is that the treatment of lung cancer has not improved drastically in the past few years. Lung tumors are also potentially difficult to treat with radiation therapy due the patients' respiration motion causing the tumor to be mobile.

A1) Detrimental effects of respiration motion Respiration motion affects all tumor sites in the thorax and abdomen, although the disease of most prevalence and relevance for radiotherapy is lung cancer. Many studies have been performed to study lung-tumor motion and methods to compensate for this motion during radiation treatment imaging, planning and delivery. The significance of the respiration motion compensation techniques is to reduce the mobility of the tumors and thereby reduce the dose to the surrounding normal structures. If no motion compensation methods are used then a margin must be added to ensure adequate coverage of the tumor. Large margins results in radiation delivered to a larger volume of critical structures.

A2) Compensation techniques Methods that reduce respiration induced intrafraction motion include active breathing control, voluntary breath-hold, deep inspiration breath-hold, respiratory gated techniques, and 4D or tumor-tracking techniques.1-6 Active breathing control and the deep inspiration breath hold involves the patient holding their breath. While these may improve the reproducibility of the position of the tumor within the lung, it is not feasible for all patients especially those that have a compromised respiratory function. Respiratory gating techniques involves turning on the beam during only a small window of the respiratory cycle. Thus respiratory gating reduces the intrafraction motion but does not totally eliminate it. During respiratory gating, since the beam is turned on and off based on the respiration signal, the treatment time may increase up to 35-40% compared to a regular treatment. Since the patient has to spend more time on the table, this could introduce more errors due to patient movement on the table. 4D or tumor tracking techniques has it own share of issues as is discussed in the following paragraph.

A3) During 4D radiotherapy (4DRT) delivery the tumor is continuously tracked with the radiation beam as they move throughout the respiratory cycle. The benefits of 4DRT are a reduction in dose to the healthy lung tissue and/or an increase in dose to the tumor. The gains from 4DRT are clinically measurable, though much development is needed in the various steps of 4DRT i.e. CT image acquisition, planning and delivery.

During 4D CT image acquisition, images are acquired during different respiration states of normal breathing.7-9 The quality of images acquired by using the 4D CT image acquisition is limited by patients respiration pattern. Since the images are sorted based on the patients respiration motion, any change in pattern could lead to the images being sorted to a different part of respiration. This effect is reflected as an artifact on the CT image.

Target volumes along with respiration motion can be determined by contouring the target in the various respiratory states thus obtaining a volume that encompasses an entire breathing cycle. The efficacy and accuracy of 4D CT will be maximized when patients breathe reproducibly. However it is well-known that respiration motion varies not only from one day to the next but also during one fraction.

A4) Effect of irregular breathing For 4D CT, minimizing the variation of patient breathing within a treatment fraction and from fraction to fraction, i.e., increasing the reproducibility of patient breathing, is important. Large variation in patient respiration motion and irregular breathing lead to artifacts in the CT images as shown in. However, respiration motion amplitude and period vary with time and from patient to patient because of various anatomic and physiologic factors.

A5) Possible solutions Biofeedback/coaching techniques are being increasingly embedded in the behavioral treatment of patients with lung disease such as chronic obstructive pulmonary disease, asthma, and cystic fibrosis. For respiratory gating, several studies suggest that verbal prompts improve respiration reproducibility. Kini et al.12 concluded that audio prompts improve the stability of respiration frequency of the patient but does not maintain the range of respiratory motion, whereas visual prompts control only the regularity of the displacement and the frequency is not reproducible. Based on the results of Kini et al.12, combined audio-visual biofeedback was devised to improve the reproducibility of respiration motion. Recently Neicu et al.13 described results of audio and visual prompting and demonstrated improvement in the efficacy of so-called synchronized moving aperture radiation therapy, using respiratory traces from single-patient and volunteer sessions.

George et al.14 concluded based on a 24-patient, multisession study that audio-visual biofeedback can significantly reduce residual motion variability for a given duty cycle, thus potentially improving the accuracy of respiratory-gating. From the results of this study it was seen that audio-visual biofeedback reduced motion by 0.5 cm (0.29 to 0.24 cm) for exhale breathing and 1.5 cm (0.46 to 0.36 cm) for inhale breathing.

Tipo de estudo

Observacional

Inscrição (Real)

25

Contactos e Locais

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Locais de estudo

    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21201
        • University of Maryland

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

18 anos a 86 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

Patients with Abdominal & Thoracic malignancies who consent to recieving Radiation treatment at the University of Maryland, Baltimore, will be offered this protocol design.

Descrição

Inclusion Criteria:

  • Patients 18 years old or older
  • Patients undergoing a scan in the Department of Radiation Oncology for a thoracic or abdominal lesion(s) and identified as candidates for 4D CT.

Exclusion Criteria:

  • Pregnant or breast-feeding women are excluded.
  • Negative serum or urine pregnancy test prior to study entry is required. Once on the protocol, the patient will be advised and expected to implement an accepted and effective method of contraception such as oral contraceptives ('the pill'),intrauterine devices (IUD's), contraceptive implants under skin or contraceptive injections and condoms with foam.
  • Patients who have difficulty lying flat on their back for extended periods of time will be excluded.

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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
To assess the efficacy of audio visual biofeedback for reducing artifacts for 4 -dimensional computer tomography (4DCT)
Prazo: 8 scans over 3 days
8 scans over 3 days

Medidas de resultados secundários

Medida de resultado
Prazo
To evaluate improvement in acquisition of a 4D CT by using audio-visual biofeedback including acquisition procedure, tumor quality
Prazo: 8 scans over 3 days
8 scans over 3 days

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Warren D'Souza, PhD, University of Maryland, Baltimore

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

1 de novembro de 2008

Conclusão Primária (Real)

1 de agosto de 2011

Conclusão do estudo (Real)

1 de agosto de 2011

Datas de inscrição no estudo

Enviado pela primeira vez

24 de outubro de 2008

Enviado pela primeira vez que atendeu aos critérios de CQ

24 de outubro de 2008

Primeira postagem (Estimativa)

27 de outubro de 2008

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de março de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de março de 2020

Última verificação

1 de março de 2020

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • HP-00043968

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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