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

This study has been completed.
Sponsor:
Collaborator:
Società Italiana di Radiologia Medica
Information provided by (Responsible Party):
Sergio Salerno, University of Palermo
ClinicalTrials.gov Identifier:
NCT01436006
First received: July 28, 2011
Last updated: July 7, 2015
Last verified: July 2015
  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 University of Palermo:

Primary Outcome Measures:
  • Value of Mean CTDI Vol for Head CT Examinations. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Value of Mean CTDI Vol for Chest CT Examinations. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Value of Mean CTDI Vol for Abdomen CT Examinations. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Value of Mean CTDI Vol for Cardiac CT Examinations. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Value of Mean CTDI Vol for Chest Abdomen and Pelvis CT Examinations. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Value of Mean CTDI Vol for Spine CT Examinations. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 28, 2011
Results First Received: May 26, 2014
Last Updated: July 7, 2015
Health Authority: Italy: Ministry of Health

Keywords provided by University of Palermo:
MDCT
radiation
dose

ClinicalTrials.gov processed this record on September 03, 2015