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

NCT ID: NCT02760706

Last Updated: 2017-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

303 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-09-30

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Computed Tomography scan

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Philips Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert C Gilkeson,, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Prabhakar Rajiah,, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

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University Hospitals Case Medical Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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SDCTUH08-13-12

Identifier Type: -

Identifier Source: org_study_id

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