Completed

NCT Number: NCT01737333

Multidetector Computed Tomography (MDCT) Tailored Protocol

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oepedale Niguarda, Milan, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

Bracco Diagnostics, Inc

Industry

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Nov 29, 2012
Registry last updated: Sep 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.