Preliminary Assessment of Added Diagnostic Value of Dual Energy CT Images Using Data Acquired on a Spectral Detector CT
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|ClinicalTrials.gov Identifier: NCT02760706|
Recruitment Status : Completed
First Posted : May 4, 2016
Last Update Posted : May 19, 2017
Study hypothesis: Post-processed SDCT images provide additional diagnostic value over conventional CT datasets.
The CT examination would be a clinically-necessary, standard-of-care CT performed as per the clinical indication. The protocol and scan parameters for the CT exam will be similar to that of an equivalent scan performed with any other CT scanner. There would be no additional scanner of injection of any drug specifically for the study. The conventional CT images generated by the scanner will be used for clinical purposes as routinely practiced.
|Condition or disease||Intervention/treatment|
|Compare Image Quality Between SDCT and Conventional CT Images of Any Tissue Lesion, Determine Optimal Monochromatic Energy Level for a Coronary Artery Image||Device: Computed Tomography scan|
|Study Type :||Observational|
|Actual Enrollment :||303 participants|
|Official Title:||Preliminary Assessment of the Added Diagnostic Value of Dual Energy Computed Tomography (DECT) Images Using Data Acquired on a Spectral Detector Computed Tomography (SDCT)|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
- Determine if Post-processed SDCT images provide additional diagnostic value over conventional CT datasets. [ Time Frame: 6 months ]Data will be recorded as mean +/- standard deviation for each parameter. Student's t test and Wilcoxon's test will be performed to compare objective and subjective data respectively. In addition, differences on lesion detection and characterization, sensitivity, specificity and accuracy of conventional CT and SDCT images will be compared using a receiver operating curve (ROC) analysis. Additionally, agreement between both readers will be evaluated using Cohen´s kappa test (poor agreement for κ ≤ 0.19; fair agreement for κ = 0.2-0.39; moderate agreement for κ = 0.4-0.59, substantial agreement for κ = 0.6-0.79 and very good agreement for κ = 0.8-1.00; 19). A P value of <0.05 will be required for statistical significant difference.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02760706
|United States, Ohio|
|University Hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Robert C Gilkeson,, M.D.||University Hospitals Cleveland Medical Center|
|Principal Investigator:||Prabhakar Rajiah,, M.D.||University Hospitals Cleveland Medical Center|