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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01172041
First received: July 26, 2010
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating the Role of Audiovisual Biofeedback on Image Quality During 4D Anatomic and Functional Imaging

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Measure the difference in number of artifacts on 4D CT scans using audiovisual biofeedback in comparison to Free breathing. [ Time Frame: Day one ] [ Designated as safety issue: No ]
    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.


Enrollment: 10
Study Start Date: July 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172041

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Bill Loo Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01172041     History of Changes
Other Study ID Numbers: LUN0026, 98393, SU-05152009-2578, 10886
Study First Received: July 26, 2010
Last Updated: July 8, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fluorodeoxyglucose F18
Diagnostic Uses of Chemicals
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiopharmaceuticals

ClinicalTrials.gov processed this record on October 20, 2014