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

Pediatric Patients Undergoing a Computed Tomography Examination Clinical Trial

— PedCTBe  

Official title:

National Study of Low Dose Effects of X-rays in Pediatric Patients Undergoing a CT Examination.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01518673
• Other study ID #: 2010/708
• Status: Completed
• Start date: February 2012
• Est. completion date: June 2015

Study information

• Verified date: November 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Years

Eligibility

Inclusion Criteria:

• pediatric patients wearing a catheter

Exclusion Criteria:

Related Conditions & MeSH terms

• Pediatric Patients Undergoing a Computed Tomography Examination

Intervention

Procedure:
• Blood test
Analysing X-ray induced genetic effects in pediatric patients directly after a computer tomography scan.

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	Federal Agency for Nuclear Control, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	X-ray induced genetic effects in pediatric patients directly after a computed tomography scan.	Assessment of ? -H2AX foci in peripheral blood lymphocytes.	Within 30 min after the computed tomography examination.

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