Clinical Trial: Cone Beam CT for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Cone Beam CT (CS 9300) for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose
Brief Summary: The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT. It proposes a direct comparison of diagnostic image quality between the CS 9300 and conventional CT using double image examinations.
Detailed Summary: The diagnostic image quality between the CS 9300 and conventional CT using double image examinations.
Sponsor: Carestream Health, Inc.
Current Primary Outcome: Diagnostic Image Quality [ Time Frame: Patients will be followed until each has had their standard of care CT and the investigational CBCT an expected average of 3 hours. ]
This study will try to prove that CBCT images are not diagnostically worse than conventional CT for overall image quality and visibility of pathologic attributes, including conspicuity, for all disease types and defects of the sinus region and temporal bone.
After all Data is collected from the three sites, a Reader Study will be conducted to access diagnostic image quality.
Original Primary Outcome: Same as current
Current Secondary Outcome: Dose Levels to sensitive body parts [ Time Frame: Patients will be followed until each has had their standard of care CT and the investigational CBCT an expected average of 3 hours. ]
CBCT images captures at a minimum of 65% reduction in dose compared to conventional CT. This study will try to prove that dose levels to thyroid, breast and gonad are less using CBCT than conventional CT.
After the 5 patients who are randomly selected to wear dosimeters are imaged. A statistical analysis will be performed on the data.
Original Secondary Outcome: Same as current
Information By: Carestream Health, Inc.
Dates:
Date Received: May 6, 2013
Date Started: September 2012
Date Completion:
Last Updated: January 30, 2017
Last Verified: September 2013
