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Sponsored by: |
National Institutes of Health Clinical Center (CC) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00059137 |
This study will evaluate the effectiveness of a flexible belt device in guiding patient breathing during computed tomography (CT)-guided needle biopsy. When patients undergo CT scanning to help guide the physician during a tissue biopsy, they are usually asked to hold their breath while the scan is taken of certain parts of the body. When the first scan is completed, the patients are allowed to breathe, and are then asked to hold their breath again while the needle is advanced towards the tissue to be biopsied. Since body organs and tissues move with breathing, this study will try to stop the patient's breathing at the same place in the breathing cycle to ensure that the biopsy target stays still and in the same place. This study will see if the flexible belt, used with a computer screen that charts the patient's breathing, will improve the patient's ability to stop breathing at the same place in the breathing cycle before and during the biopsy.
Patients 18 years of age and older who have a lesion requiring a needle biopsy in the chest or abdominal area may be eligible for this study. The biopsy procedure must require CT scan guidance.
Participants will undergo the following procedures:
Condition |
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Needle Biopsy CAT Scan X-Ray |
Study Type: | Observational |
Official Title: | Respiratory Cycle Biofeedback During CT Guided Procedures |
Estimated Enrollment: | 30 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | March 2006 |
This study will examine the use of a flexible belt placed across the patient's abdomen to sense and plot the patient's respiratory cycle. The point in the respiratory cycle at which the patient holds his/her breath will be recorded at different levels and correlated with CT scans and prior patient breathing levels. Our hypothesis is that a graphical representation of the respiratory cycle may make it easier for the patient to hold his or her breath at the same level each time a CT scan is obtained, or a needle is inserted. If this is true, then this should translate into faster safer procedures, with potentially less ionizing radiation, although this endpoint is not defined in this particular study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Patients must fulfill all of the following criteria to be eligible for study admission:
EXCLUSION CRITERIA:
Patients with any of the following will be excluded from study entry:
Study ID Numbers: | 030166, 03-CC-0166 |
Study First Received: | April 18, 2003 |
Last Updated: | March 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00059137 |
Health Authority: | United States: Federal Government |
Gating Respiratory Misregistration Abdominal Belt Percutaneous |
CT Guided Biopsy Respiratory Cycle Needle Biopsy |