Multidetector Computed Tomography (MDCT) Tailored Protocol

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

Official title:

A Multicenter, Multinational, Randomized Study of Standard vs. Patient-Adapted Protocols in Multidetector Computed Tomography (MDCT) of the Chest, Abdomen, Liver or Aorta

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01737333
• Other study ID #: IOPM-101
• Status: Completed
• Phase: N/A
• First received: November 20, 2012
• Last updated: September 27, 2013
• Start date: October 2012
• Est. completion date: July 2013

Study information

• Verified date: September 2013
• Source: Bracco Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1493
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Italy	Oepedale Niguarda	Milan
United States	Department of Radiology Carolinas Medical Center	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Quality	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).	Immediately after the single injection of contrast agent	No