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OpenTrials
Completed

NCT Number: NCT01172041

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Real time position management system

Device

Device to monitor respiration by using optical monitoring of a marker block placed on the abdomen of the patient.

Other names: Varian

LS PET/CT

Device

PET/CT scanner for acquiring CT and PET images (3D and 4D)

Other names: GE

18-FDG

Drug

15mCi

Other names: Fludeoxyglucose (18F), fluorodeoxyglucose (18F)

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 29, 2010
Registry last updated
Jul 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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