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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University Ghent.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 October 23, 2014