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Multidetector Computed Tomography (MDCT) Tailored Protocol

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ClinicalTrials.gov Identifier: NCT01737333
Recruitment Status : Completed
First Posted : November 29, 2012
Last Update Posted : September 30, 2013
Sponsor:
Information provided by (Responsible Party):
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.

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

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 Type : Observational
Actual Enrollment : 1493 participants
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
Study Start Date : October 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans
U.S. FDA Resources




Primary Outcome Measures :
  1. Diagnostic Quality [ Time Frame: 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT01737333     History of Changes
Other Study ID Numbers: IOPM-101
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: September 30, 2013
Last Verified: September 2013