Assessment the influence of CT scan administrated contrast agents on radiation dose calculation in treatment planning of radiotherapy compared to the calculation based on non-enhanced CT scan in patients with cancer of the rectum, prostate and cervix
The aim of this self-controlled clinical trial study with before/after method is to assess the influence of CT scan administrated contrast (oral-intravenous) results in significant difference on radiation dose calculation compared to the standard calculation based on non-enhanced CT scans. Eleven patients with cancer of pelvic region (rectum, prostate and cervix) are included in this study and undergo computed tomography simulation without and with administrated contrast in the same position and coordinates. Patients with renal diseases, diabetes, asthma, prior reactions to drugs and contrast agents are excluded. First, each patient will receive one to two 20mL vial of the Meglumine compound (Gastrografin) with a concentration of 370 mg of iodine per ml. This oral solution dissolved in 1.5L of mineral water and a fourth of the solution administrated to each patient every half an hour. Then, each patient will receive 1-2mL per kilogram Iodixanol (Visipaque) 320mgI/ml as intravenous contrast agent. Contrast-enhanced images were obtained 65 seconds after intravenous contrast. Finally, obtained CT images (without and with contrast) will be transferred to the ISOGRAY treatment planning software (made by France) for calculating the differences in radiation dose distribution.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051922319N1
Registration date:2015-06-03, 1394/03/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-03, 1394/03/13
Registrant information
Name
Sahel Heydarheydari
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3729 0469
Email address
a.haghparast@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-08-21, 1394/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the influence of CT scan administrated contrast agents on radiation dose calculation in treatment planning of radiotherapy compared to the calculation based on non-enhanced CT scan in patients with cancer of the rectum, prostate and cervix
Public title
CT scan administrated contrast agents effect on radiation dose calculation in treatment planning of radiotherapy
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Patients referred to the Radiotherapy-Oncology ward because of the rectum, prostate and cervix cancers;
Exclusion criteria: Renal diseases, Diabetes, Allergic asthma, Food and Drug allergies, Prior reactions to contrast agents and taking some drugs like Metformin
Age
From 15 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
11
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
This study is a self controlled clinical trial in a before/after method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Vice chancellor for research, Kermanshah University of Medical sciences
Street address
Vice chancellor for research, Building number two, Shahid Beheshti Blvd
City
Kermanshah
Postal code
6714673159
Approval date
2015-02-17, 1393/11/28
Ethics committee reference number
kums.rec.1394.12
Health conditions studied
1
Description of health condition studied
Rectum cancer
ICD-10 code
C20
ICD-10 code description
Malignant neoplasm of rectum
2
Description of health condition studied
Prostate cancer
ICD-10 code
C61
ICD-10 code description
Malignant neoplasm of prostate
3
Description of health condition studied
Cervix cancer
ICD-10 code
C53, C53.0
ICD-10 code description
Malignant neoplasm of cervix uteri
Primary outcomes
1
Description
Radiation dose
Timepoint
Before and after the intervention
Method of measurement
Dosimetry with treatment planning system
Secondary outcomes
empty
Intervention groups
1
Description
Interventions 1: Meglumine compound 370mgI/ml as oral contrast and Iodixanol 320mgI/ml as intravenous contrast
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Radiotherapy Oncology Unit , Imam Reza Hospital
Full name of responsible person
Dr. Negin Farshchian
Street address
Imam Reza Hospital, Zakaria Razi Blvd
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Dr.Abbas Haghparast
Street address
Vice chancellor for research, Building number two, Shahid Beheshti Blvd,
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sahel Heydarheydari
Position
Post-Graduated Student in Medical Physics
Other areas of specialty/work
Street address
Department of Biomedical Physics and Engineering, Faculty of Medicine, Parastar Blvd