Ignite Creation Date:
2024-05-05 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 9:57 AM
Study NCT ID:
NCT00780611
Status:
COMPLETED
Last Update Posted:
2020-03-18
First Post:
2008-10-24
Brief Title:
Investigating the Improvement in 4D CT Images Using AV Biofeedback
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Investigating the Improvement in 4D CT Images Using Audiovisual Biofeedback An Intra-fraction and an Inter-fraction Evaluation
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GCC0832
Brief Summary:
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
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
Detailed Description:
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 techniques1-6 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 andor 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 ie CT image acquisition planning and delivery
During 4D CT image acquisition images are acquired during different respiration states of normal breathing7-9 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 ie 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 Biofeedbackcoaching 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 al12 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 al12 combined audio-visual biofeedback was devised to improve the reproducibility of respiration motion Recently Neicu et al13 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 al14 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 05 cm 029 to 024 cm for exhale breathing and 15 cm 046 to 036 cm for inhale breathing
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 techniques1-6 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 andor 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 ie CT image acquisition planning and delivery
During 4D CT image acquisition images are acquired during different respiration states of normal breathing7-9 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 ie 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 Biofeedbackcoaching 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 al12 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 al12 combined audio-visual biofeedback was devised to improve the reproducibility of respiration motion Recently Neicu et al13 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 al14 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 05 cm 029 to 024 cm for exhale breathing and 15 cm 046 to 036 cm for inhale breathing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None