X-Ray Computed Tomography and Blood Reactive Oxygen Species Level

This study has been terminated.
(Beacuse of unexpected administrative barriers, only 5 cases were enrolled in a year.)
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00712998
First received: July 9, 2008
Last updated: May 17, 2009
Last verified: March 2008
  Purpose

The clinically widely used X-ray computed tomography examination has a low-grade radiation effect and recently has attracted much attention concerning the possible adverse effects of radiation on human body [ref. 1-5]. The radiation is harmful to human tissues and cells mainly because it can interact with water (which makes up to 80% of cells) to generate reactive oxygen species (ROS), especially the formation of hydroxyl radicals. So far as we can reach, there is no report concerning the relation between X-ray computed tomography examination and the blood ROS concentration. Therefore, we wish to conduct this study to clarify if the routinely applied X-ray computed tomography examination may induce a higher concentration of ROS in the peripheral blood.

Study subjects will be participants of health check program at our hospital. The only enrollment condition will be a scheduled X-ray computed tomography examination for either lung (20 cases) or heart (20 cases) of the study subject. Another 20 participants receiving health check program without X-ray computed tomography examination will be included as the control group. The formal consent will be delivered to the participants of health check program several days before their admission for health check and will be retrieved before the proceeding of health check.

Measurements and comparison of ROS concentration will be performed in the sampled peripheral blood before and after the performance of X-ray computed tomography examination during a regular health check program. Totally 120 blood samples will be collected from included 60 study subjects within 3 months. Reactive oxygen species(ROS)levels will be measured by a chemiluminescence (CL) analysing system (CLD-110, Tohoku Electronic Industrial, Sendai, Japan).


Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effect of X-Ray Computed Tomography Examination on the Blood Reactive Oxygen Species Level in Apparently Healthy Adults

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Biospecimen Retention:   None Retained

only peripheral blood will be collected for measurement of reactive oxygen species.


Estimated Enrollment: 60
Study Start Date: May 2008
Estimated Study Completion Date: July 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Twenty subjects receiving health check program without X-ray computed tomography examination will be included as the control group.
2
Twenty subjects receiving health check program including X-ray computed tomography examination of lung will be included as the treatment group-1.
3
Twenty subjects receiving health check program including X-ray computed tomography examination of heart will be included as the treatment group-2.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

participants of health check program at our hospital

Criteria

Inclusion Criteria:

  • Participants of health check program at our hospital who will receive a scheduled X-ray computed tomography examination for either lung (20 cases) or heart (20 cases).

Exclusion Criteria:

  • Those whose age are under 50 or above 70 year-olds will be excluded.
  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: NCT00712998

Locations
Taiwan
NTUH
Taipei, Taiwan, 10016
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Zei-Shung Huang, MD, PhD NTUH
  More Information

No publications provided

Responsible Party: Zei-Shung Huang, associate professor, Department of Internal Medicine, NTUH, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00712998     History of Changes
Other Study ID Numbers: 200803085R
Study First Received: July 9, 2008
Last Updated: May 17, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
radiation injuries
free radicals
reactive oxygen species
radiation injury from X-ray computed tomography
free radical production
blood reactive oxygen species level

ClinicalTrials.gov processed this record on September 18, 2014