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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

Tracking Information
First Submitted Date November 24, 2013
First Posted Date May 4, 2016
Last Update Posted Date May 19, 2017
Study Start Date October 2013
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 29, 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02760706 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Preliminary Assessment of Added Diagnostic Value of Dual Energy CT Images Using Data Acquired on a Spectral Detector CT
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)
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients requiring a clinically-necessary CT scan
Condition Compare Image Quality Between SDCT and Conventional CT Images of Any Tissue Lesion, Determine Optimal Monochromatic Energy Level for a Coronary Artery Image
Intervention Device: Computed Tomography scan
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 18, 2017)
303
Original Estimated Enrollment
 (submitted: April 29, 2016)
150
Actual Study Completion Date September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02760706
Other Study ID Numbers SDCTUH08-13-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Philips Healthcare
Study Sponsor Philips Healthcare
Collaborators Not Provided
Investigators
Principal Investigator: Robert C Gilkeson,, M.D. University Hospitals Cleveland Medical Center
Principal Investigator: Prabhakar Rajiah,, M.D. University Hospitals Cleveland Medical Center
PRS Account Philips Healthcare
Verification Date May 2017