| CTRI Number |
CTRI/2018/12/016618 [Registered on: 11/12/2018] Trial Registered Prospectively |
| Last Modified On: |
04/02/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Establishing diagnostic reference level ofradiation dose and using low dose protocol for CT head in pediatric population |
|
Scientific Title of Study
|
Establishing Diagnostic Reference level and optimization of radiation dose for Computed Tomography of head in Pediatric Population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka |
| Designation |
Assistant Professor |
| Affiliation |
School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Medical Imaging Tehnology, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09739314908 |
| Fax |
|
| Email |
priyanka.rao@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Priyanka |
| Designation |
Assistant Professor |
| Affiliation |
School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Medical Imaging Tehnology, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09739314908 |
| Fax |
|
| Email |
priyanka.rao@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka |
| Designation |
Assistant Professor |
| Affiliation |
School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Medical Imaging Tehnology, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09739314908 |
| Fax |
|
| Email |
priyanka.rao@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical Collage and Hospital, Manipal- 576104 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Priyanka |
Kasturba Medical College and Hospital,Manipal |
Room NO. : 2 ,128 Slice Philips Incisive CT Scanner,
Department Of Radio
Diagnosis And Imaging,
Kasturba Medical Collage and Hospital, Manipal,Udupi,
Karnataka 576104
Udupi
KARNATAKA |
9739314908
priyanka.rao@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Hospital, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G938||Other specified disorders of brain, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Pediatric patients referred for CT head with age range of 0- 5 years
|
|
| ExclusionCriteria |
| Details |
Pediatric patients referred for Contrast enhanced CT brain and Un co-operative patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
CTDI vol (mGy)
DLP- Dose Length Product (mGy.cm)
Effective dose (mSv)
DRL- Diagnostic Reference Level |
CTDIvol and DLP- will be noted at the end of each scan
Effective dose (mSv) will be calculated from DLP
CTDIvol and DLP will be used to calculate DRL |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjective and Objective image quality Assessment
|
Subjective and Objective image quality Assessment - weekly one time |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
17/12/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The study is a cross sectional observational study and will be done in two phase.
Phase 1: Include 143 patients.Scanning will be performed using standard pediatric brain protocol. Dose info such as CTDI vol and DLP will be noted at the end of the scan and effective dose will be calculated from DLP. The 3rd quartile value of CTDI vol and DLP will be calculated to establish Diagnostic Reference Levels.
Phase2: Scanning will be performed using low dose pediatric brain protocol. Dose info such as CTDI vol and DLP will be noted at the end of the scan and effective dose will be calculated from DLP. Subjective and objective assessment of image quality will be done. The 3rd quartile value of CTDI vol and DLP will be calculated to establish Diagnostic Reference Levels for low dose. |