Investigating the Improvement in 4D CT Images Using AV Biofeedback (GCC0832)
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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. |
- To assess the efficacy of audio visual biofeedback for reducing artifacts for 4 -dimensional computer tomography (4DCT) [ Time Frame: 8 scans over 3 days ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| 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| Ages Eligible for Study: | 18 Years to 86 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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.
Contacts and Locations| United States, Maryland | |
| University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| Principal Investigator: | Warren D'Souza, PhD | University of Maryland, Baltimore County |
More Information
No publications provided
| Responsible Party: | Department of Radiation Oncology, Principal Investigator, University of Maryland |
| ClinicalTrials.gov Identifier: | NCT00780611 History of Changes |
| Other Study ID Numbers: | HP-00043968 |
| Study First Received: | October 24, 2008 |
| Last Updated: | January 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Lung Neoplasms Abdominal Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013