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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00780611
First Posted: October 27, 2008
Last Update Posted: March 17, 2015
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.
Information provided by (Responsible Party):
Department of Radiation Oncology, University of Maryland
  Purpose

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
Cancer of the Lung Abdominal Cancer

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Department of Radiation Oncology, University of Maryland:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 25
Study Start Date: November 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 86 Years   (Adult, Senior)
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.
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00780611


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

Responsible Party: Department of Radiation Oncology, Principal Investigator, University of Maryland
ClinicalTrials.gov Identifier: NCT00780611     History of Changes
Other Study ID Numbers: HP-00043968
First Submitted: October 24, 2008
First Posted: October 27, 2008
Last Update Posted: March 17, 2015
Last Verified: March 2015

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