1. Home
  2. Approved trials
  3. » فارسی

Assessment of a high-pass radiation shield on image quality in patients undergoing computed tomography (CT)

View the latest revision

History
# Registration date Revision Id
2 2019-12-05, 1398/09/14 132845
1 2018-11-15, 1397/08/24 67116
Changes made to previous revision

  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents

  • Protocol summary

    Assessment of the effect of copper- bismuth shield on the image quality of patients undergoing thoracic , head and neck, pelvis and stomach CT examination
    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
    بررسی اثر محافظ پرتویی مس-بیسموت بر روی کیفیت تصویر بیماران تحت تصویربرداری سی تی قفسه سینه، سر و گردن و شکم و لگن
    بررسی اثر محافظ پرتویی بالاگذر بر روی کیفیت تصویر بیماران تحت تصویربرداری سی تی قفسه سینه، سر و گردن و شکم و لگن
    A multi center, single blinded for outcome assessment, controlled trial with a parallel group design
    A single-blinded for outcome assessment, controlled trial with a parallel-group design
    کارآزمایی بالینی چند مرکزی با دو گروه موازی، کنترل شده و یکسو کور برای ارزیابی کننده نتایج
    کارآزمایی بالینی با دو گروه موازی، کنترل شده و یکسو کور برای ارزیابی کننده نتایج
    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.
    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.
    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.
    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.
    گروه مداخله: بر روی پستان، تیروئید، چشم، تخمدان و بیضه بیماران مراجعه کننده برای تصویربرداری سی تی اسکن از قفسه سینه، سر و گردن و شکم و لگن محافظ پرتویی مس بیسموت قرار خواهد گرفت. شیلد مس بیسموت ترکیبی از مس، بیسموت و سیلیکون می باشد که توسط خود محقق ساخته شده و قبلا بر روی فانتوم تست شده است. هنگام تصویر برداری، شیلد توسط تکنولوژیست بر روی فوم سه سانتی بر روی بافت قرار داده شده و تماسی با بدن نخواهد داشت. هر بیمار یکبار تحت مداخله قرار گرفته و نیازی به آموزش بیماران نیست. گروه کنترل: بیماران مراجعه کننده برای تصویربرداری از قفسه سینه، سر، گردن، شکم و لگن بدون هیچ مداخله ای تحت تصویر برداری روتین قرار خواهند گرفت.
    گروه مداخله: بر روی پستان، تیروئید، چشم، تخمدان و بیضه بیماران مراجعه کننده برای تصویربرداری سی تی اسکن از قفسه سینه، سر و گردن و شکم و لگن محافظ پرتویی بالاگذر قرار خواهد گرفت. شیلد بالاگذر توسط خود محقق ساخته شده و قبلا بر روی فانتوم تست شده است. هنگام تصویر برداری، شیلد توسط تکنولوژیست بر روی فوم سه سانتی بر روی بافت قرار داده شده و تماسی با بدن نخواهد داشت. هر بیمار یکبار تحت مداخله قرار گرفته و نیازی به آموزش بیماران نیست. گروه کنترل: بیماران مراجعه کننده برای تصویربرداری از قفسه سینه، سر، گردن، شکم و لگن بدون هیچ مداخله ای تحت تصویر برداری روتین قرار خواهند گرفت.

  • General information

    2019-10-23, 1398/08/01
    2020-08-22, 1399/06/01
    empty
    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.
    empty
    1- در ثبت کارآزمایی حاضر، اسم حفاظ تحت عنوان " مس -بیسموت" ذکر شده که یک اشتباه تایپی بوده و اسم حفاظ " حفاظ بالاگذر" می باشد. مس و بیسموت جزو ترکیبات استفاده شده در ساختار این حفاظ بوده ولی اسم آن مس -بیسموت نیست. بدین جهت اسم حفاظ در عنوان و متن کارآزمایی تصحیح گردید. 2- زمان خاتمه بیمارگیری تا آخر شهریور سال 99 تمدید شد. 3- امکان بیمار گیری در بیمارستان گناباد مقدور نبود و بدین جهت بیمارستان امام رضا به عنوان تنها مرکز مطالعه در نظر گرفته شد.
    Effect of Copper-Bismuth shield on image quality of CT scan
    Effect of high-pass radiation shield on image quality of CT scan
    اثر محافظ پرتویی مس-بیسموت بر کیفیت تصاویر سی تی اسکن
    اثر محافظ پرتویی بالاگذر بر کیفیت تصاویر سی تی اسکن
    Assessment of new Copper-Bismuth shield on image quality in patients undergoing computed tomography (CT)
    Assessment of a high-pass radiation shield on image quality in patients undergoing computed tomography (CT)
    بررسی اثر محافظ پرتویی جدید مس-بیسموت بر کیفیت تصویر در بیماران تحت تصویربرداری سی تی اسکن
    بررسی اثر محافظ پرتویی بالاگذر بر کیفیت تصویر در بیماران تحت تصویربرداری سی تی اسکن

  • Intervention groups

    #1
    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.
    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.
    گروه مداخله: بر روی پستان، تیروئید، چشم، تخمدان و بیضه بیماران مراجعه کننده برای تصویربرداری سی تی اسکن از قفسه سینه، سر و گردن و شکم و لگن محافظ پرتویی مس بیسموت قرار خواهد گرفت. شیلد مس بیسموت ترکیبی از مس، بیسموت و سیلیکون می باشد که توسط خود محقق ساخته شده و قبلا بر روی فانتوم تست شده است. هنگام تصویر برداری، شیلد توسط تکنولوژیست بر روی فوم سه سانتی بر روی بافت قرار داده شده و تماسی با بدن نخواهد داشت. هر بیمار یکبار تحت مداخله قرار گرفته و نیازی به آموزش بیماران نیست.
    گروه مداخله: بر روی پستان، تیروئید، چشم، تخمدان و بیضه بیماران مراجعه کننده برای تصویربرداری سی تی اسکن از قفسه سینه، سر و گردن و شکم و لگن محافظ پرتویی بالاگذر قرار خواهد گرفت. شیلد بالاگذر توسط خود محقق ساخته شده و قبلا بر روی فانتوم تست شده است. هنگام تصویر برداری، شیلد توسط تکنولوژیست بر روی فوم سه سانتی بر روی بافت قرار داده شده و تماسی با بدن نخواهد داشت. هر بیمار یکبار تحت مداخله قرار گرفته و نیازی به آموزش بیماران نیست.

  • Recruitment centers

    #1
    Name of recruitment center - English: Imam Reza Hospital
    Name of recruitment center - Persian: بیمارستان امام رضا
    Full name of responsible person - English: Valiallah Saba
    Full name of responsible person - Persian: ولی الله صبا
    Street address - English: Etemadzadeh street, AJA University of Medical Sciences
    Street address - Persian: خیابان اعتمادزاده، دانشگاه علوم پزشکی ارتش
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 43822449
    Phone: +98 21 4382 2449
    Fax:
    Email: vsaba@aut.ac.ir
    Web page address:
    Name of recruitment center - English: Imam Reza Hospital
    Name of recruitment center - Persian: بیمارستان امام رضا
    Full name of responsible person - English: Valiallah Saba
    Full name of responsible person - Persian: ولی الله صبا
    Street address - English: Imam Reza hospital, Etemadzadeh street, Fatemi Street, Tehran
    Street address - Persian: تهران، خیابان فاطمی، خیابان اعتمادزاده، بیمارستان امام رضا
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1411718541
    Phone: +98 21 4382 2449
    Fax:
    Email: vsaba@aut.ac.ir
    Web page address:
    #2
    Name of recruitment center - English: Allame bohlool Gonabadi hospital
    Name of recruitment center - Persian: بیمارستان علامه بهلول گنابادی
    Full name of responsible person - English: Mohammad keshtkar
    Full name of responsible person - Persian: محمد کشتکار
    Street address - English: Allame Bohlool Gonabadi hospital, vahdat boulevard, sadi street, Gonabad, khorasan razavi
    Street address - Persian: خراسان رضوی، گناباد، خیابان سعدی، بلوار وحدت، بیمارستان علامه بهلول گنابادی
    City - English: Gonabad
    City - Persian: گناباد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9691797852
    Phone: +98 51 5723 6833
    Fax:
    Email: info@gmu.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr.Zareian
    Full name of responsible person - Persian: دکتر زارعیان
    Street address - English: Etemadzadeh street
    Street address - Persian: خیابان اعتمادزاده
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1411718541
    Phone: +98 21 8609 6350
    Fax:
    Email: info@ajaums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Armin Zareian
    Full name of responsible person - Persian: دکتر آرمین زارعیان
    Street address - English: AJA university of medical sciences, Etemadzadeh Street, Fatemi Street, Tehran
    Street address - Persian: تهران، خیابان فاطمی، خیابان اعتمادزاده، دانشگاه علوم پزشکی ارتش
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1411718541
    Phone: +98 21 8609 6350
    Fax:
    Email: info@ajaums.ac.ir
    Web page address:

Protocol summary

Study aim
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
Design
A single-blinded for outcome assessment, controlled trial with a parallel-group design
Settings and conduct
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.
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: 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.
Main outcome variables
Image quality

General information

Reason for update
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.
Acronym
IRCT registration information
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
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
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of a high-pass radiation shield on image quality in patients undergoing computed tomography (CT)
Public title
Effect of high-pass radiation 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, Fatemi street, Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
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: 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.
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
Imam Reza hospital, Etemadzadeh street, Fatemi Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 4382 2449
Email
vsaba@aut.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr Armin Zareian
Street address
AJA university of medical sciences, Etemadzadeh Street, Fatemi Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
info@ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Valiallah Saba
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Imaging Technology
Street address
Etemadzadeh Street, Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 4382 2449
Fax
Email
vsaba@aut.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Valiallah Saba
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Imaging Technology
Street address
Etemadzadeh street, Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 4382 2449
Fax
Email
vsaba@aut.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Valiallah Saba
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Imaging Technology
Street address
Etemadzadeh Street, Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 4382 2449
Fax
Email
vsaba@aut.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Their is no further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The study protocle, data analysis method, the study outcomes and results will be shared.
When the data will become available and for how long
When the study completed.
To whom data/document is available
researchers in academic institutions
Under which criteria data/document could be used
Any analyses is permissible.
From where data/document is obtainable
Referring to Dr. Valiallah saba by email: vsaba@aut.ac.ir
What processes are involved for a request to access data/document
Submission of request by email
Comments
Loading...