Completed

NCT Number: NCT02760706

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

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computed Tomography scan

Device

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Philips Healthcare

Industry

Registry information

Official study 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)

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: May 4, 2016
Registry last updated: May 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.