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Low Dose Effects of X-rays in Pediatric Patients Undergoing a CT Examination. (PedCTBe)

This study is currently recruiting participants.
Verified July 2012 by University Ghent
Sponsor:
Collaborator:
Federal Agency for Nuclear Control, Belgium
Information provided by (Responsible Party):
University Ghent
ClinicalTrials.gov Identifier:
NCT01518673
First received: January 20, 2012
Last updated: July 26, 2012
Last verified: July 2012
History of Changes
  Purpose

Patients undergoing a computed tomography are exposed to a relatively high dose of X-rays. Pediatric patients are known to be very radiosensitive with respect to radiation induced cancer. Using the technique of scoring γ-H2AX foci in peripheral blood lymphocytes the most important lesions to the genetic material DNA, double strand breaks induced by CT X-rays can be detected. The technique will be applied in a multicenter setting for evaluation of X-effects induced by a computed tomography examination in a population of pediatric patients. To this end a blood sample will be taken from the patients before and after the examination.


Condition Intervention
Pediatric Patients Undergoing a Computed Tomography Examination
 Procedure: Blood test

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: National Study of Low Dose Effects of X-rays in Pediatric Patients Undergoing a CT Examination.

Resource links provided by NLM:

MedlinePlus related topics: CT Scans X-Rays
U.S. FDA Resources

Further study details as provided by University Ghent:

Primary Outcome Measures:
  • X-ray induced genetic effects in pediatric patients directly after a computed tomography scan. [ Time Frame: Within 30 min after the computed tomography examination. ] [ Designated as safety issue: Yes ]
    Assessment of γ -H2AX foci in peripheral blood lymphocytes.


Biospecimen Retention:   Samples With DNA

Blood lymphocytes


Estimated Enrollment: 120
Study Start Date: February 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
X-rays Procedure: Blood test
Analysing X-ray induced genetic effects in pediatric patients directly after a computer tomography scan.

  Eligibility

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric patients undergoing computed tomography are exposed to a relatively high dose of X-rays.

Criteria

Inclusion Criteria:

  • pediatric patients wearing a catheter

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01518673

Contacts
Contact: Peter Smeets, MD peter.smeets@uzgent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Peter Smeets, MD         peter.smeets@uzgent.be    
Sponsors and Collaborators
University Ghent
Federal Agency for Nuclear Control, Belgium
Investigators
Principal Investigator: Peter Smeets, MD University Hospital, Ghent
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT01518673     History of Changes
Other Study ID Numbers: 2010/708
Study First Received: January 20, 2012
Last Updated: July 26, 2012
Health Authority: Belgium: Ethics Committee

ClinicalTrials.gov processed this record on May 23, 2013