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The Role of Audiovisual Biofeedback on Image Quality During 4D Anatomic and Functional Imaging

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ClinicalTrials.gov Identifier: NCT01172041
Recruitment Status : Completed
First Posted : July 29, 2010
Last Update Posted : July 1, 2016
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Description
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Brief Summary:
This study will investigate whether audiovisual biofeedback, in which visual and audio cues are used to regulate the patient's breathing, can increase the image quality of 4D CT and 4D PET scans.

Condition or disease Intervention/treatment
Lung Cancer Device: Real time position management system Device: LS PET/CT Drug: 18-FDG

Study Design
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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating the Role of Audiovisual Biofeedback on Image Quality During 4D Anatomic and Functional Imaging
Study Start Date : July 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: Real time position management system
    Device to monitor respiration by using optical monitoring of a marker block placed on the abdomen of the patient.
    Other Name: Varian
  • Device: LS PET/CT
    PET/CT scanner for acquiring CT and PET images (3D and 4D)
    Other Name: GE
  • Drug: 18-FDG
    15mCi
    Other Names:
    • Fludeoxyglucose (18F)
    • fluorodeoxyglucose (18F)

Outcome Measures
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Primary Outcome Measures :
  1. Measure the difference in number of artifacts on 4D CT scans using audiovisual biofeedback in comparison to Free breathing. [ Time Frame: Day one ]
    The first, third, fifth seventh and ninth patients accrued to the protocol will have their free breathing studies performed first. The second, fourth, sixth, eighth and tenth patients accrued to the protocol will have their audiovisual (a/v) biofeedback studies performed first.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosis of AJCC Stage I-III lung cancer of any histology to be treated using radiotherapy at Stanford Cancer Center
Criteria

Inclusion Criteria:

Required for inclusion in this study are:

  • Informed consent
  • Diagnosis of AJCC Stage I-III lung cancer of any histology to be treated using radiotherapy at Stanford Cancer Center
  • Age 18 or greater
  • Painfree in supine position
  • Karnofsky performance status 50 or greater

The inclusion of educationally disadvantaged, decisionally impaired or homeless people are allowed if informed consent, in the opinion of the consenting investigator (study PI, co-PI or research nurse), is obtained.

Exclusion Criteria:

No

  • Pregnant women
  • Stanford employees
  • Stanford students
  • Prisoners will be eligible for the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01172041


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Bill Loo Stanford University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01172041    
Other Study ID Numbers: LUN0026
98393 ( Other Identifier: Stanford University Alternate IRB Approval Number )
SU-05152009-2578 ( Other Identifier: Stanford University )
10886 ( Other Identifier: Stanford IRB )
First Posted: July 29, 2010    Key Record Dates
Last Update Posted: July 1, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action