Fabrication and determination of the effect of optimal radiation shield made of silicon-barium sulfate on breast radiation dose in chest CT scan imaging
Design
Clinical trial, one blind, randomized, on 23 patients
Settings and conduct
After obtaining an informed consent form from the patients referred for a chest CT scan at Allameh Bahloul Gonabad Hospital, a radiation shield is placed on the chest of the patients undergoing chest CT imaging. It should be noted that the shield will be made for one breast so that one breast (on which the radiation shield is placed) can be used as the case group and the other breast as the control group. After taking thirty images T is removed from the breast using Shadow Shields software so that the right and left breast images are the same and the images are evaluated
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 or older
Consent to participate in the study
Non-entry criteria:
Patients with unilateral or bilateral mastectomy
Patients with a low level of consciousness
Intervention groups
Placing a silicon barium sulfate shield on the left breast during chest CT scan imaging in women referred to Allameh Bahloul Gonabadi Hospital and evaluating its effect and comparing the image of the left breast (with radiation shielding) and the right side (without shielding).
Main outcome variables
Artifact, radiation dose, noise, signal to noise ratio
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230413057892N1
Registration date:2023-04-29, 1402/02/09
Registration timing:prospective
Last update:2023-04-29, 1402/02/09
Update count:0
Registration date
2023-04-29, 1402/02/09
Registrant information
Name
Saeede Yazdanifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3028
Email address
s.yadanifar1130@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-30, 1402/02/10
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Fabrication and assessment the effect of optimized radiation shield made of silicone-barium sulfate on radiation dose of breast in thoracic CT imaging
Public title
Fabrication and assessment the effect of optimized radiation shield made of silicone-barium sulfate on radiation dose of breast in thoracic CT imaging
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 or older
Consent to participate in the study
Exclusion criteria:
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
23
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
After taking the CT images, the shields are removed from the breast using the shadow software so that the right and left breast images are the same, and then the radiologist checks the images.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Gonabad university of medical sciences , DR Mahdiade street
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2022-12-24, 1401/10/03
Ethics committee reference number
IR.GMU.REC.1401.112
Health conditions studied
1
Description of health condition studied
Fabrication and assessment the effect of optimized radiation shield made of silicone-barium sulfate on radiation dose of breast in thoracic CT imaging
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Breast radiation dose
Timepoint
After chest CT scan
Method of measurement
Pen dosimeter
2
Description
Image artifact
Timepoint
After chest CT scan
Method of measurement
Checklist or questionnaire
3
Description
Image noise
Timepoint
After chest CT scan
Method of measurement
Software
4
Description
Signal to noise ratio
Timepoint
After chest CT scan
Method of measurement
Software
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Placing the shield on the right breast
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Allameh Bahloul Gonabad Hospital
Full name of responsible person
Saeede Yazdanifar
Street address
Gonabad university of medical sciences , DR Mahdiade street
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
S.yazdanifar1130@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr Leila Sadeq moghadam
Street address
Gonabad university of medical sciences , DR Mahdiade street
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
S.yazdanifar1130@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Saeede Yazdanifar
Position
student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Gonabad university of medical sciences , DR Mahdiade street
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
S.yazdanifar1130@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Saeede Yazdanifar
Position
student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Gonabad university of medical sciences , DR Mahdiade street
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
S.yazdanifar1130@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Saeede Yazdanifar
Position
student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Gonabad university of medical sciences , DR Mahdiade street
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
S.yazdanifar1130@gmail.com
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available