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

NCT01172041 | Completed DMC

• 4 other identifiers: LUN002698393SU-05152009-257810886
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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.

Also known as: Varian

LS PET/CT DEVICE

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

Also known as: GE

18-FDG DRUG

15mCi

Also known as: Fludeoxyglucose (18F), fluorodeoxyglucose (18F)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Pregnant women
• Stanford employees
• Stanford students
• Prisoners will be eligible for the study.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• Yang J, Yamamoto T, Pollock S, Berger J, Diehn M, Graves EE, Loo BW Jr, Keall PJ. The impact of audiovisual biofeedback on 4D functional and anatomic imaging: Results of a lung cancer pilot study. Radiother Oncol. 2016 Aug;120(2):267-72. doi: 10.1016/j.radonc.2016.05.016. Epub 2016 May 30.

  PMID: 27256597 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Bill Loo

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: July 29, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 1, 2016

Record last verified: 2016-06

Locations

US (1)