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

NCT02760706 | Completed

• 1 other identifier: SDCTUH08-13-12
• Study Type: observational
• Target: 303
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Interventions

Computed Tomography scan DEVICE

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients requiring a clinically-necessary CT scan

You may qualify if:

• 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.

You may not qualify if:

• under the age of 18 years old

Sponsors & Collaborators

• Philips Healthcare: lead

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Interventions

Tomography, X-Ray Computed

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Robert C Gilkeson,, M.D.

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

• Prabhakar Rajiah,, M.D.

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2013
• First Posted: May 4, 2016
• Study Start: October 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 19, 2017

Record last verified: 2017-05

Locations

US (1)