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CTRI Number  CTRI/2019/01/017294 [Registered on: 28/01/2019] Trial Registered Prospectively
Last Modified On: 23/06/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To provide optimized radiation level values for head & neck and pelvic cancer radiotherapy CT Planning. 
Scientific Title of Study   Establishing diagnostic reference levels and optimization of radiation dose for head and neck and pelvic computed tomography protocols in radiation therapy planning 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  shreekripa 
Designation  Asst. Prof in Medical Physics 
Affiliation  MAHE 
Address  Dept of Radiotherapy and Oncology, SOAHS, KMC, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9844990988  
Fax    
Email  rao.shreekripa@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  shreekripa 
Designation  Asst. Prof in Medical Physics 
Affiliation  MAHE 
Address  Dept of Radiotherapy and Oncology, SOAHS, KMC, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9844990988  
Fax    
Email  rao.shreekripa@gmail.com  
 
Details of Contact Person
Public Query
 
Name  shreekripa 
Designation  Asst. Prof in Medical Physics 
Affiliation  Manipal Academy of Higher Education (MAHE) 
Address  Dept of Radiotherapy and Oncology, SOAHS, KMC, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9844990988  
Fax    
Email  rao.shreekripa@gmail.com  
 
Source of Monetary or Material Support  
Source is Grants by The Director, R&DD, AERB Niyamak Bhavan, Anushakti Nagar, Mumbai-400 094. Application submitted to AERB 
 
Primary Sponsor  
Name  Atomic Energy Regulatory board AERB 
Address  The Director, R&DD, Atomic Energy Regulatory board (AERB), Niyamak Bhavan, Anushakti Nagar, Mumbai-400 094.  
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shreekripa  Kasturba Hospital  Room No 13, CT Room, Dept of Radiotherapy and Oncology, , Kasturba Hospital, KMC, MAHE, Manipal
Udupi
KARNATAKA 
9844990988

rao.shreekripa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KH and KMC Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D||Radiation Therapy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Cancer patients referred for CT head and neck and pelvic region with age 18 and above
 
 
ExclusionCriteria 
Details  Un co-operative patients, Patients with dental fillings, Patients with metal prosthesis. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Standardization of Radiotherapy Planning CT head and Neck and pelvic protocol and optimization of dose can be achieved by using the reference DRLs.  Within 1.5 years of time outcome will be assessed and estimated 
 
Secondary Outcome  
Outcome  TimePoints 
The study will be useful in reduction of radiation-induced effects.  Within 1.5 years of time the outcome will be assessed and estimated 
 
Target Sample Size   Total Sample Size="215"
Sample Size from India="215" 
Final Enrollment numbers achieved (Total)= "430"
Final Enrollment numbers achieved (India)="430" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   06/02/2019 
Date of Study Completion (India) 31/01/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Study Procedure

Before initiating scan, the participant will be explained about the study and written informed consent will be obtained. The age and sex of the participants will be recorded, the following parameters will be collected from CT console for CT examination of head and neck and pelvic such as Tube potential, Tube current, Scan time, Rotation time, Slice thickness, Slice beam collimation, Pitch, Total slices, Field of view, start couch level and end couch level, Reconstruction algorithm that will be used.

The patients will be in supine position on flat couch and immobilization device fixed to particular area of scan with reference markers, head first into the gantry. Centre the table height such that the external auditory meatus is at the center of the gantry. Scanning will be performed using present Onco scan protocol.

CT dose quantities

The two dosimetric quantities namely CTDIvol and DLP will be recorded from dose info for each patient at the end of scan from CT console. CTDIvol will be given in milligray (mGy) and describes the average dose for a volume in either sequential or a helical sequence. DLP will be given in milligray centimeters (mGy.cm) and it is combination of CTDIvol and the scan length that described the total radiation dose received by the patients undergoing CT scans.

Effective dose will be calculated using formula:

E= k x DLP

E= effective dose, K= conversion factor, DLP= Dose Length Product

Phase II: Study Procedure

Optimizing CT radiation dose with respect to CT acquisition parameters would ideally accomplished by conducting the studies based on observer. Initially this can be performed by acquiring CT image of Phantom with different combination of kV and mAs. To find balance between CT image quality and radiation dose, the scans will be acquiring with a Catphan 503 at specified parameters like

Rotation time – 0.5 s/1sec

Slice thickness – 2.5 mm/ 3mm / 5mm

Pitch – 0.813

mAs and kV – all combinations available in CT scanner

After CT acquisition the data will be reconstructed using different algorithms. The reconstructed images will be reviewed by experienced Oncologists and Medical Physicists. By using optimal parameters obtained by analysis of phantom data will be used to create protocols based on optimum parameters.

 

 
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