Preliminary Assessment of Added Diagnostic Value of Dual Energy CT Images Using Data Acquired on a Spectral Detector CT

Philips Healthcare303 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

303

Conditions

Compare Image Quality Between SDCT and Conventional CT Images of Any Tissue Lesion, Determine Optimal Monochromatic Energy Level for a Coronary Artery Image

Interventions

Computed Tomography scanDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * a patient scheduled for a clinically indicated CT scan for one or more of the following body regions/organ systems: * head and neck * body (chest and abdomen/pelvis) * cardiovascular structures. * these scans may be without contrast, with contrast enhancement, or CT angiograms. Exclusion Criteria: * under the age of 18 years old * standard exclusion criteria for CT scans

Outcomes

Primary Outcomes

Determine if Post-processed SDCT images provide additional diagnostic value over conventional CT datasets.

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.

Time frame: 6 months