Protocol summary
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Study aim
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Assessment of the effect of the high-pass radiation shield on the image quality of patients undergoing thoracic, head and neck, pelvis and stomach CT examination
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Design
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A single-blinded for outcome assessment, controlled trial with a parallel-group design
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Settings and conduct
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In the CT scan imaging department, after filling the informed consent form, a high-pass radiation shield will be placed over the target organs of patients undergoing CT examination. For blinding, before assessing CT images by radiologists, pictures of the shield will be removed from CT images. A questionnaire will be filled by the radiologists about the quality of images. Different levels of artifacts will be scored by radiologists.
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Participants/Inclusion and exclusion criteria
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Patients undergoing thoracic, head and neck, pelvis and stomach CT examination will be recruited in the study except those with contrast-enhancement agent injection
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Intervention groups
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Intervention group: High-pass radiation 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 high-pass radiation shield 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 a 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.
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Main outcome variables
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Image quality
General information
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Reason for update
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1. During the registering process of this trial, the name of "copper-bismuth" was considered as the name of the constructed shield. This is only a writing mistake and the name of the constructed shield is "high-pass shield". copper and bismuth are the materials used in the shield composition; however, the name of the shield is not " copper-bismuth.
2. The end of the trial was extended until August 2020.
3. It was not possible to recruit patients in gonabad hospital. so, the Imam Reza hospital is considered as the sole center for recruiting the patients.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180730040642N1
Registration date:
2018-11-15, 1397/08/24
Registration timing:
registered_while_recruiting
Last update:
2020-05-06, 1399/02/17
Update count:
1
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Registration date
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2018-11-15, 1397/08/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-10-23, 1397/08/01
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Expected recruitment end date
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2020-08-22, 1399/06/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Assessment of a high-pass radiation shield on image quality in patients undergoing computed tomography (CT)
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Public title
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Effect of high-pass radiation shield on image quality of CT scan
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients undergoing head, neck, pelvis and stomach or thoracic CT examinations
Exclusion criteria:
Patients with contrast- enhancment agents injection
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Age
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From 20 years old to 75 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
160
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-09-25, 1397/07/03
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Ethics committee reference number
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IR.AJAUMS.REC.1397.027
Health conditions studied
1
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Description of health condition studied
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Protection of radiosensitive organs against radiation in CT scan
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Image quality
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Timepoint
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After thoracic, head and neck, or pelvis and stomach CT imaging
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Method of measurement
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Filling a questionnaire about image quality by 3 radiologists
Intervention groups
1
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Description
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Intervention group: high-pass radiation 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 high-pass radiation shield 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.
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Category
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Prevention
2
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Description
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Control group: Patients will undergo routine CT imaging of head, neck or thorax and pelvis and stomach without any further action.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Artesh University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Their is no further information
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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The study protocle, data analysis method, the study outcomes and results will be shared.
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When the data will become available and for how long
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When the study completed.
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To whom data/document is available
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researchers in academic institutions
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Under which criteria data/document could be used
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Any analyses is permissible.
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From where data/document is obtainable
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Referring to Dr. Valiallah saba by email: vsaba@aut.ac.ir
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What processes are involved for a request to access data/document
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Submission of request by email
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Comments
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