Multidetector Computed Tomography (MDCT) Tailored Protocol

NCT ID: NCT01737333

Last Updated: 2013-09-30

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

1493 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-07-31

Brief Summary

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Collection of data from different sites regardless of whether they use standard or tailored protocols for the application of high concentration iodinated contrast agents to assess if the individually patient-adapted protocols result in a similar diagnostic image quality.

Detailed Description

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To record technical information and compare image quality regarding routine MDCT procedures with contrast administration using a tailored contrast injection and radiation dose protocol. The hypotheses are that the tailored protocols lead to a lower applied mean radiation dose compared to the use of standard protocols and will provide a more standardized contrast dose per patient size without impairing diagnostic quality.

Conditions

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Patients Undergoing Contrast Enhanced Multidetector Computed Tomography of the Chest, Abdomen, Liver or Aorta for Any Diagnostic Cause

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age
* Scheduled to undergo contrast enhanced MDCT of the abdomen, liver, aorta, or chest
* Provides written informed consent

Exclusion Criteria

* Previously enrolled and completed the study
* Known allergy to iodinated contrast media
* Pregnancy or lactation
* Clinically unsuitable for the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bracco Diagnostics, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Krix, M.D.

Role: STUDY_DIRECTOR

Bracco Diagnostics, Inc

Locations

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Department of Radiology Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

Oepedale Niguarda

Milan, , Italy

Site Status

Countries

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United States Italy

Other Identifiers

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IOPM-101

Identifier Type: -

Identifier Source: org_study_id