Investigating the Improvement in 4D CT Images Using AV Biofeedback (GCC0832)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00780611
Recruitment Status : Completed
First Posted : October 27, 2008
Last Update Posted : March 17, 2015
Information provided by (Responsible Party):
Department of Radiation Oncology, University of Maryland

Brief Summary:

This study will look at how tumors in the chest and abdomen move when you breathe. Your doctors are studying if extra 4D CT scans and instructions on how to breathe can help predict this type of movement and improve the accuracy of radiation treatment. 4D CT scans are approved by the FDA. A 4D CT scan is different from a regular CT because it moves slower and takes more pictures. It takes pictures of the way your body moves when you breathe. This gives doctors more pictures of your body so that they can match your pictures to the way you breathe.

In this study, instructions on how to breathe will be visual and audio. Visual instructions will be given to you on a computer screen. You will hear audio instructions through a speaker.

Condition or disease
Cancer of the Lung Abdominal Cancer

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Investigating the Improvement in 4D CT Images Using Audiovisual Biofeedback: An Intra-fraction and an Inter-fraction Evaluation.
Study Start Date : November 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To assess the efficacy of audio visual biofeedback for reducing artifacts for 4 -dimensional computer tomography (4DCT) [ Time Frame: 8 scans over 3 days ]

Secondary Outcome Measures :
  1. To evaluate improvement in acquisition of a 4D CT by using audio-visual biofeedback including acquisition procedure, tumor quality [ Time Frame: 8 scans over 3 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 86 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with Abdominal & Thoracic malignancies who consent to recieving Radiation treatment at the University of Maryland, Baltimore, will be offered this protocol design.

Inclusion Criteria:

  • Patients 18 years old or older
  • Patients undergoing a scan in the Department of Radiation Oncology for a thoracic or abdominal lesion(s) and identified as candidates for 4D CT.

Exclusion Criteria:

  • Pregnant or breast-feeding women are excluded.
  • Negative serum or urine pregnancy test prior to study entry is required. Once on the protocol, the patient will be advised and expected to implement an accepted and effective method of contraception such as oral contraceptives ('the pill'),intrauterine devices (IUD's), contraceptive implants under skin or contraceptive injections and condoms with foam.
  • Patients who have difficulty lying flat on their back for extended periods of time will be excluded.

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 identifier (NCT number): NCT00780611

United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Principal Investigator: Warren D'Souza, PhD University of Maryland

Responsible Party: Department of Radiation Oncology, Principal Investigator, University of Maryland Identifier: NCT00780611     History of Changes
Other Study ID Numbers: HP-00043968
First Posted: October 27, 2008    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases