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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
Sponsor:
Information provided by (Responsible Party):
Philips Healthcare

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 303 participants
Observational Model: Case-Only
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients requiring a clinically-necessary CT scan
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Philips Healthcare
Investigators
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Principal Investigator: Robert C Gilkeson,, M.D. University Hospitals Cleveland Medical Center
Principal Investigator: Prabhakar Rajiah,, M.D. University Hospitals Cleveland Medical Center

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Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT02760706     History of Changes
Other Study ID Numbers: SDCTUH08-13-12
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017