Multidetector Computed Tomography (MDCT) Tailored Protocol
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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 |
|---|
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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 |
- 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).
| Estimated Enrollment: | 1920 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
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 |
Patients undergoing MDCT of the abdomen, liver, chest or aorta and receiving high iodinated contrast agents
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| Contact: Ilya Trusov, M.D. | 609-514-2231 | ilya.trusov@diag.bracco.com |
| United States, North Carolina | |
| Department of Radiology Carolinas Medical Center | Not yet recruiting |
| Charlotte, North Carolina, United States, 28203 | |
| Italy | |
| Oepedale Niguarda | Recruiting |
| Milan, Italy, 20162 | |
| 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: | November 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on May 22, 2013