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Adult and Paediatric Patient Radiation Doses From Multidetector Row Computed Tomography Scans: a National Survey (MDCTDOSE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01436006
First Posted: September 19, 2011
Last Update Posted: September 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Società Italiana di Radiologia Medica
Information provided by (Responsible Party):
Sergio Salerno, University of Palermo
  Purpose

The situation in Italy regarding radiation dose to patients undergoing Multidetector row Computed Tomography (MDCT) scans is unclear despite Italian law require that each centre check the Reference Dose Level (RDL) every two years. RDL in CT were first suggested in a document of 1998 published by the European Commission (EUR16262/1998) based on the results of an older survey in the UK from the late 1980s. Those RDLs, expressed in terms of Computed Tomography Dose Index (CTDI) and Dose Length Product (DLP), are reported in the Italian law (D.Lgs.187/00). However, in Italy there is no governmental authority comparable to the UK's National Radiological Protection Board, deputed to dose evaluation and protection.

An overview of the Italian situation is relevant in order to know the actual dose levels for MDCT administered to patients both adults and paediatrics.


Condition
Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Adult and Paediatric Patient Radiation Doses From Multidetector CT Scans: a National Survey

Resource links provided by NLM:


Further study details as provided by Sergio Salerno, University of Palermo:

Primary Outcome Measures:
  • Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Head CT Examinations. [ Time Frame: One year ]
  • Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Chest CT Examinations. [ Time Frame: one year ]
  • Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Abdomen CT Examinations. [ Time Frame: one year ]
  • Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Cardiac CT Examinations. [ Time Frame: one year ]
  • Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Chest Abdomen and Pelvis CT Examinations. [ Time Frame: one year ]
  • Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Spine CT Examinations. [ Time Frame: one year ]

Enrollment: 6700
Study Start Date: February 2011
Study Completion Date: June 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
CT scan
patient with cancer

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient that will need a CT scan between March 2011 and February 2012
Criteria

Inclusion Criteria:

  • Patients that will be submitted to "standard" protocols for CT of the: head, chest, abdomen, lumbar spine and cardiac

Exclusion Criteria:

  • Non standard MDCT examination
  Contacts and Locations
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): NCT01436006


Locations
Italy
Azienda Ospedaliero Universitaria Policlinico
Palermo, Italy/Sicily, Italy, 90127
Sponsors and Collaborators
University of Palermo
Società Italiana di Radiologia Medica
Investigators
Principal Investigator: Sergio Salerno, Prof. University of Palermo
Study Director: Daniela Origgi, PhD European Institute of Oncology
  More Information

Publications:
Responsible Party: Sergio Salerno, Associate Professor, University of Palermo
ClinicalTrials.gov Identifier: NCT01436006     History of Changes
Other Study ID Numbers: MDCTDOSE/SIRM
First Submitted: July 28, 2011
First Posted: September 19, 2011
Results First Submitted: May 26, 2014
Results First Posted: August 4, 2015
Last Update Posted: September 18, 2015
Last Verified: September 2015

Keywords provided by Sergio Salerno, University of Palermo:
MDCT
radiation
dose