Assessment of the effect of copper- bismuth shield on the image quality of patients undergoing thoracic , head and neck, pelvis and stomach CT examination
Design
A multi center, single blinded for outcome assessment, controlled trial with a parallel group design
Settings and conduct
In CT scan imaging department, after filling informed consent form, Copper-bismuth shield will be placed over target organ of patients undergoing CT examination. For blinding, before assessing CT images by radiologist, pictures of shield will be removed from CT images. A questionaire will be filled by the radiologist about the quality of images. Different level of artefacts will be scored by radiologist.
Participants/Inclusion and exclusion criteria
Patients undergoing thoracic, head and neck, pelvis and stomach CT examination will be recruited in the study except those with contrast-enhancement agent injection
Intervention groups
Intervention group: Copper bismuth shield will be placed over breasts, thyroid, eyes, testes and ovaries of the patients undergoing thoracic, head and neck, and stomach and pelvis CT examination. The copper bismuth shield is made of a combination of copper, bismuth, and silicon that was constructed by the researcher of the current study and tested on phantom recently. During imaging, the shield will be positioned over a foam of 3 cm width over the target organs of the patients and will not have any contact with the patient’s body. The shield will be used once on every patient and the patients do not need any education about it. Control group: patients will undergo routine CT imaging of head, neck or thorax and pelvis and stomach without any further action.
Main outcome variables
Image quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180730040642N1
Registration date:2018-11-15, 1397/08/24
Registration timing:registered_while_recruiting
Last update:2018-11-15, 1397/08/24
Update count:1
Registration date
2018-11-15, 1397/08/24
Registrant information
Name
Valiallah Saba
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3268 5305
Email address
vsaba@aut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of new Copper-Bismuth shield on image quality in patients undergoing computed tomography (CT)
Public title
Effect of Copper-Bismuth shield on image quality of CT scan
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing head, neck, pelvis and stomach or thoracic CT examinations
Exclusion criteria:
Patients with contrast- enhancment agents injection
Age
From 20 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The CT images will be analysed and interpreted by radiologists. To have unbiased interpretation, the radiologists will be blinded by removing the image of shield from the reconstructed images.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of AJA University of Medical Sciences
Street address
etemadzadeh street
City
Tehran
Province
Tehran
Postal code
88888888
Approval date
2018-09-25, 1397/07/03
Ethics committee reference number
IR.AJAUMS.REC.1397.027
Health conditions studied
1
Description of health condition studied
Protection of radiosensitive organs against radiation in CT scan
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Image quality
Timepoint
After thoracic, head and neck, or pelvis and stomach CT imaging
Method of measurement
Filling a questionnaire about image quality by 3 radiologists
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Copper bismuth shield will be placed over breasts, thyroid, eyes, testes and ovaries of the patients undergoing thoracic, head and neck, and stomach and pelvis CT examination. the copper bismuth shield is made of a combination of copper, bismuth, and silicon was constructed by the researcher of the current study and tested on phantom recently. during imaging, the shield will be positioned over a foam of 3 cm width over the target organs of the patients and will not have any contact with the patients body. the shield will be used once on every patient and the patients do not need any education about it.
Category
Prevention
2
Description
Control group: Patients will undergo routine CT imaging of head, neck or thorax and pelvis and stomach without any further action.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Valiallah Saba
Street address
Etemadzadeh street, AJA University of Medical Sciences