Multidetector Computed Tomography (MDCT) Tailored Protocol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT01737333
First received: November 20, 2012
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • Diagnostic Quality [ Time Frame: Immediately after the single injection of contrast agent ] [ Designated as safety issue: No ]
    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).


Enrollment: 1493
Study Start Date: October 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients undergoing MDCT of the abdomen, liver, chest or aorta and receiving high iodinated contrast agents

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737333

Locations
United States, North Carolina
Department of Radiology Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Italy
Oepedale Niguarda
Milan, Italy, 20162
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
Study Director: Martin Krix, M.D. Bracco Diagnostics, Inc
  More Information

No publications provided

Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT01737333     History of Changes
Other Study ID Numbers: IOPM-101
Study First Received: November 20, 2012
Last Updated: September 27, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 17, 2014