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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United States1 site
  • University of Maryland

    Baltimore, Maryland, 21201

Other trials in United States

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.

Medical subject headings
Lung Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  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.

  1. First posted27 Oct 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionAug 2011
  4. Study completionAug 2011

Resources

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)
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

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.

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