Cancer of the LungGCC0832NCT00780611
Investigating the Improvement in 4D CT Images Using AV Biofeedback
An observational study of Cancer of the Lung and Abdominal Cancer, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 86 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer of the Lung, Abdominal Cancer
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 86 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Abdominal \& Thoracic malignancies who consent to recieving Radiation treatment at the University of Maryland, Baltimore, will be offered this protocol design.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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 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.
- Conditions
- Cancer of the Lung, Abdominal Cancer
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of audio visual biofeedback for reducing artifacts for 4 -dimensional computer tomography (4DCT)
Measured: 8 scans over 3 days
Secondary outcomes (1)
To evaluate improvement in acquisition of a 4D CT by using audio-visual biofeedback including acquisition procedure, tumor quality
Measured: 8 scans over 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the LungStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Department of Radiation Oncology, University of Maryland, Baltimore
- Investigators
- Warren D'Souza, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780611
- Sponsor's protocol ID
- HP-00043968
- Acronym
- GCC0832
- Status last verified
- Mar 2020
- First submitted
- 24 Oct 2008
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Improvement in 4D CT Images Using Audiovisual Biofeedback: An Intra-fraction and an Inter-fraction Evaluation.
- ClinicalTrials.gov ID
- NCT00780611
- Acronym / sponsor ID
- GCC0832 / HP-00043968
- Conditions
- Cancer of the Lung, Abdominal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 27 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Abdominal \& Thoracic malignancies who consent to recieving Radiation treatment at the University of Maryland, Baltimore, will be offered this protocol design.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the efficacy of audio visual biofeedback for reducing artifacts for 4 -dimensional computer tomography (4DCT)
Time frame: 8 scans over 3 days
1 secondary outcome
To evaluate improvement in acquisition of a 4D CT by using audio-visual biofeedback including acquisition procedure, tumor quality
Time frame: 8 scans over 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warren D'Souza, PhD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of the Lung and Abdominal Cancer, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy of audio visual biofeedback for reducing artifacts for 4 -dimensional computer tomography (4DCT) (time frame: 8 scans over 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.