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

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ClinicalTrials.gov Identifier: NCT01518673
Recruitment Status : Unknown
Verified December 2014 by University Ghent.
Recruitment status was:  Recruiting
First Posted : January 26, 2012
Last Update Posted : December 5, 2014
Sponsor:
Collaborator:
Federal Agency for Nuclear Control, Belgium
Information provided by (Responsible Party):
University Ghent

Brief Summary:
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 or disease Intervention/treatment
Pediatric Patients Undergoing a Computed Tomography Examination Procedure: Blood test

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: National Study of Low Dose Effects of X-rays in Pediatric Patients Undergoing a CT Examination.
Study Start Date : February 2012
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
X-rays Procedure: Blood test
Analysing X-ray induced genetic effects in pediatric patients directly after a computer tomography scan.



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


Biospecimen Retention:   Samples With DNA
Blood lymphocytes


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
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:


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): 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

Additional Information:
Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT01518673     History of Changes
Other Study ID Numbers: 2010/708
First Posted: January 26, 2012    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014