Design and fabrication of radioprotective shield to reduce the radiation dose to the breast in patients undergoing thoracic computed tomography examinations
Design and fabrication of radioprotective shield to reduce the radiation dose to the breast in patients undergoing thoracic computed tomography examinations
Design
A clinical trial with a control group with parallel group, double-blind and non-randomized on 60 female patients aged 20-75 years.
Settings and conduct
Gonabad University of Medical Sciences - Allameh Bahloul Hospital
Participants/Inclusion and exclusion criteria
The criteria for patients to enter the plan are female patients aged 20 to 75 years who are subject to a lung CT scan, and the criteria for patients to leave the plan are patients who have a decreased level of consciousness or the patient's lack of consent to continue participating in the research.
Intervention groups
The intervention group of 30 female patients who had the best radiation shield placed on their chest during lung CT and the control group of 30 female patients who did not have any radiation shield placed on their chest during lung CT
Main outcome variables
Investigation of noise and average CT number in CTDI phantom CT images with and without radiation shields, measurement of thorax and breast phantom with and without radiation shields, artifact investigation in lung CT images of female patients without radiation shield and with the best radiation shield .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230411057881N1
Registration date:2023-05-21, 1402/02/31
Registration timing:registered_while_recruiting
Last update:2023-05-21, 1402/02/31
Update count:0
Registration date
2023-05-21, 1402/02/31
Registrant information
Name
Marziyeh Behmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3344 1022
Email address
behmadim@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-21, 1402/01/01
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design and fabrication of radioprotective shield to reduce the radiation dose to the breast in patients undergoing thoracic computed tomography examinations
Public title
Examining breast dose reduction in CT scan with a new combination of x-ray absorbing materials with minimal impact on image quality.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
20 to 75 years old woman subject to chest CT scan
Exclusion criteria:
A patient who has a reduced level of consciousness (as a result of trauma or stroke or...)
the patient's lack of consent to continue participating in the research
Age
From 20 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The radiation shield image was cut from the CT scan images of the lungs of 30 female patients with breast shields, and then the images were given to a radiologist along with the CT scans of the lungs of 30 female patients who were scanned without radiation shields on their breasts. It can be checked for the presence of artifacts (lung area, mediastinum, breast) or the absence of artifacts in the images.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd
City
Semnan
Province
Semnan
Postal code
35147-99442
Approval date
2022-12-03, 1401/09/12
Ethics committee reference number
IR.SEMUMS.REC.1401.223
Health conditions studied
1
Description of health condition studied
Dosimetry with and without chest phantom radiation shields and thorax phantom - examination of noise and average CT number in the CT scan phantom CTDI image with and without radiation shields - examination of artifacts in the chest CT scan image of female patients without and with the best shield
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Investigating noise and average CT number in CTDI phantom CT image with and without radiation protection
Timepoint
During 1months
Method of measurement
Using DICOM files software
2
Description
Chest and thorax phantom dosimetry with and without radiation shields
Timepoint
2 months
Method of measurement
Using TLD dosimeter and RTI Piranha dosimeter
3
Description
Artifact examination in lung CT images of female patients without radiation protection and with the best protection (in terms of reducing the dose and creating the least noise on the image) is placed on their chest.
Timepoint
3 months
Method of measurement
Review of images by an experienced radiologist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 female patients aged 20-75 years, on whom we put the best radiation shield (suitable dose reduction and minimal noise on the image) during lung CT.
Category
Prevention
2
Description
Control group: 30 female patients aged 20-75 years, who do not put any radiation protection on their chests during lung CT scan, and the images of this group are for comparison with the images of the intervention group in terms of image artifacts.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Allameh Bahloul Gonabad Hospital
Full name of responsible person
Mohammad Kashtkar Dastnaie
Street address
Central Headquarters of Gonabad Medical Sciences, Imam Khomeini Street, Ghadir Square
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 3513
Fax
+98 51 5723 6160
Email
Bohloolipd@gmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Marziye Behmadi
Street address
بلوار بسیج ستاد دانشگاه علوم پزشکی و خدمات بهداشتی درمانی
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3344 1022
Fax
+98 23 3344 8999
Email
Behmadim@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Marziye Behmadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
Basij Blvd., Semnan University of Medical Sciences and Healthcare Services
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3344 1022
Fax
+98 23 3344 8999
Email
behmadim@semums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Marziye Behmadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
Basij Blvd., Semnan University of Medical Sciences and Healthcare Services
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3344 1022
Fax
+98 23 3344 8999
Email
behmadim@semums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Marziye Behmadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
Basij Blvd., Semnan University of Medical Sciences and Healthcare Services
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3344 1022
Fax
+98 23 3344 8999
Email
behmadim@semums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available