Comparison of Radiation Dose Calculated by treatment planning System (TPS) of Radiation Therapy in CT Imaging of three Prostate Cancer Patients groups that have been Imaging with Three Different contrast agents Omnipaque, Visipaque and Ultravist
Comparison of the effect of 3 different prescription contrast agents in CT scan on radiation dose calculation in prostate cancer patients
Design
Among the patients referred to the CT department for treatment planning, 30 patients will be selected and each of them will have a CT scan of the abdomen and pelvis. A computer-generated randomization list will be prepared by the statistical consultant to select patients and, based on the list, another person (off-site person) who is unaware of the aims of the study (CT technologists) will inject three different contrast agents omnipaque,visipaque and ultravist to patients. Patients will be divided into three groups based on three different contrast agents, each containing ten patients. Finally, CT images will be given separately to the treatment planning software to calculate the dose distribution difference.
Settings and conduct
This study will be performed in CT scan department of Ahvaz Golestan hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: Prostate cancer patients referred to the CT scan department.
Non-inclusion criteria: Patients under 18 years; Kidney disease; Diabetes; Asthma; drug allergies
Intervention groups
Intervention group 1: Patients with prostate cancer whose CT scan will be done by intravenous injection of Omnipaque. One ml injection per body weight will be given for all 3 contrast agents. Intervention group 2: Patients with prostate cancer whose CT scan will be done by intravenous injection of Visipaque. Intervention group 3: Patients with prostate cancer whose CT scan will be done by intravenous injection of Ultravist.
Main outcome variables
radiation dose in the tumor volume , bladder and rectum
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190814044528N1
Registration date:2020-02-02, 1398/11/13
Registration timing:prospective
Last update:2020-02-02, 1398/11/13
Update count:0
Registration date
2020-02-02, 1398/11/13
Registrant information
Name
Marzieh Reshadatian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3454
Email address
m.reshadatian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Radiation Dose Calculated by treatment planning System (TPS) of Radiation Therapy in CT Imaging of three Prostate Cancer Patients groups that have been Imaging with Three Different contrast agents Omnipaque, Visipaque and Ultravist
Public title
The effect of using different contrast agents in CT scan on radiation dose during radiotherapy
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Prostate cancer patients who are referred to the CT scan ward for CT imaging and don't have the exclusion criteria
Exclusion criteria:
Patients under 18 years old
Patients with kidney problems
Diabetic patients
Patients with a history of asthma and immunological allergies
People who had allergy to the use of contrast agents in the past
Age
No age limit
Gender
Male
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
A computer-generated randomization list will be developed for patients by the statistical consultant and another off-site person with no knowledge of goals of study(CT expert) according to this list,will give patients three different contrast agents: Omnipaque, Visipaque and Ultravist.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Esfand avenue, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2019-11-23, 1398/09/02
Ethics committee reference number
IR.AJUMS.REC.1398.627
Health conditions studied
1
Description of health condition studied
Prostate Cancer
ICD-10 code
C61
ICD-10 code description
Malignant neoplasm of prostate
Primary outcomes
1
Description
Radiation dose of the patient
Timepoint
After CT imaging with injection of contrast material
Method of measurement
Radiotherapy treatment planning software (TPS)
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: prostate cancer Patients whose CT imaging done with intravenous injection of Visipaque contrast agent and it will be given a standard injection of 1 ml per kg of body weight. Imaging will take one to two minutes after intravenous injection.
Category
Diagnosis
2
Description
Second Intervention group:prostate cancer Patients whose CT imaging done with intravenous injection of Omnipaque contrast agent and it will be given a standard injection of 1 ml per kg of body weight. Imaging will take one to two minutes after intravenous injection.
Category
Diagnosis
3
Description
Third Intervention group: prostate cancer Patients whose CT imaging done with intravenous injection of Ultravist contrast agent and it will be given a standard injection of 1 ml per kg of body weight. Imaging will take one to two minutes after intravenous injection.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Sasan Razmjoo
Street address
Esfand street, Golestan region
City
Ahvaz
Province
Khouzestan
Postal code
15794 61357
Phone
+98 61 3333 3477
Email
razmjoo-s@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Badavi
Street address
Esfand street, Golestan region
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3333 3477
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Marzieh Reshadatian
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
Esfand street, Golestan region
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3333 3477
Email
m.reshadatian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohsen Cheky
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
Esfand street, Golestan region
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3336 7540
Email
mohsencheky@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Marzieh Reshadatian
Position
assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
Esfand street, Golestan region
City
Ahvaz
Province
Khouzestan
Postal code
1234567893
Phone
+98 61 3374 3454
Email
m.reshadatian@gmail.com
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
There is no need to publish raw patient data and the results of the study should be published comparatively.
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
...
When the data will become available and for how long
...
To whom data/document is available
...
Under which criteria data/document could be used
....
From where data/document is obtainable
...
What processes are involved for a request to access data/document