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 12, 2012
Last verified: July 2012
  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:
  • MDCT dose survey for the assessment of CT dose in the Italian population. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    MDCT procedure should be tailored to meet the needs of individual patient, in the mean time dose parameters should be taken in account. In-depth knowledge of patient dose levels may stimulate local programmes of dose reduction and raise radiologist awareness of MDCT in terms of dose and image quality optimization. Dose data arising from the survey may contribute to optimizing single centre standard examination protocols, monitoring CT practice and hopefully stimulate a critical review of every day CT practice.


Secondary Outcome Measures:
  • Reduction dose in MDCT in everyday practice [ Time Frame: Up to two years ] [ Designated as safety issue: Yes ]
    The survey should provide essential data on dose and techniques to facilitate further initiatives in the optimization of patient protection in MDCT. The availability of a database could be useful for on going collation of local survey data as the basis for further periodic reviews of practice and timely revision of national references doses. Hopefully this project will make radiologists aware in determining and applying correct criteria for dose reduction.


Enrollment: 7126
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
Last Updated: July 12, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by University of Palermo:
MDCT
radiation
dose

ClinicalTrials.gov processed this record on September 11, 2014