Investigating the Improvement in 4D CT Images Using AV Biofeedback - Full Text View

Sponsored by:	University of Maryland
Information provided by:	University of Maryland
ClinicalTrials.gov Identifier:	NCT00780611

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	Intervention
Abdominal Tumors Throacic Tumors	Other: 4D CT scan

MedlinePlus related topics: CT Scans Cancer Nuclear Scans

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Investigating the Improvement in 4D CT Images Using Audiovisual Biofeedback: An Intra-Fraction and an Inter-Fraction Evaluation.

Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	20
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
patient with thoracic & abdominal mailgnancy Patients undergoing a scan in the Department of Radiation Oncology for a thoracic or abdominal lesion(s) and identified as candidates for 4D CT.	Other: 4D CT scan Each patient that consents to this protocol will have four CT scans performed on the first day and three CT scans on subsequent days of the imaging protocol. On the first day that the patient arrives for CT simulation four CT scans will be performed.

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Eligibility

Ages Eligible for Study:	18 Years to 86 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780611

Contacts

Contact: Rohini George, PhD	(410) 328-3658	rgeorge@umm.edu
Contact: Ritesh S Kataria, MS	410-328-8018	rkataria@umm.edu

Locations

United States, Maryland
University Of Maryland
Baltimore, Maryland, United States, 21201

Sponsors and Collaborators

University of Maryland

Investigators

Principal Investigator:

Rohini George, PhD

University of Maryland

More Information

Responsible Party:	University of Maryland ( Dr. Rohini George )
Study ID Numbers:	H-30492, H-30492
Study First Received:	October 24, 2008
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00780611
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Abdominal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009