Multidetector Computed Tomography (MDCT) Tailored Protocol

Completed

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

• Registration Number: NCT01737333
• Lead Sponsor: Bracco Diagnostics, Inc

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-20
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-29
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-27
• Last Update Posted: 2013-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1493

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic Quality	Immediately after the single injection of contrast agent	Images are to be assessed according to the following scale: 0=Uninterpretable (Image quality severely affected by motion artifacts or technical reasons; need to repeat the examination); 1=Insufficient (Impaired image quality precludes adequate diagnostic assessment because of severe image noise or insufficient contrast enhancement; need to repeat the examination); 2=Adequate (Image quality in terms of noise and contrast enhancement does not interfere with sufficient diagnostic assessment; delineation of small structures may be suboptimal); or 3=Good (Absent or minimal image noise and good contrast enhancement allow adequate diagnostic assessment with clear delineation of even small structures).

Trial Locations

Locations (2)

Oepedale Niguarda; 🇮🇹 Milan, Italy

Department of Radiology Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States