Investigating the Improvement in 4D CT Images Using AV Biofeedback
GCC0832
1 other identifier
observational
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2008
CompletedFirst Posted
Study publicly available on registry
October 27, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedMarch 18, 2020
March 1, 2020
2.7 years
October 24, 2008
March 16, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
To assess the efficacy of audio visual biofeedback for reducing artifacts for 4 -dimensional computer tomography (4DCT)
8 scans over 3 days
Secondary Outcomes (1)
To evaluate improvement in acquisition of a 4D CT by using audio-visual biofeedback including acquisition procedure, tumor quality
8 scans over 3 days
Eligibility Criteria
Patients with Abdominal \& Thoracic malignancies who consent to recieving Radiation treatment at the University of Maryland, Baltimore, will be offered this protocol design.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Maryland
Baltimore, Maryland, 21201, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Warren D'Souza, PhD
University of Maryland, Baltimore
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 24, 2008
First Posted
October 27, 2008
Study Start
November 1, 2008
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
March 18, 2020
Record last verified: 2020-03