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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01172041
• Other study ID #: LUN0026
• Secondary ID: 98393SU-05152009
• Status: Completed
• Phase: N/A
• First received: July 26, 2010
• Last updated: June 29, 2016
• Start date: July 2010
• Est. completion date: June 2013

Study information

• Verified date: June 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

• Pregnant women

• Stanford employees

• Stanford students

• Prisoners will be eligible for the study.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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

Drug:
• 18-FDG
15mCi

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the difference in number of artifacts on 4D CT scans using audiovisual biofeedback in comparison to Free breathing.	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.	Day one	No