| CTRI Number |
CTRI/2025/11/096872 [Registered on: 04/11/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Studying and Improving Radiation Dose Levels for Children’s Chest and abdomen part CT Scans |
|
Scientific Title of Study
|
Estimation of Diagnostic Reference Levels and Optimization of Radiation Dose for Computed Tomography of Chest and Abdomen in Pediatric Population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nandini B Patil |
| Designation |
TMA Pai PhD scholar |
| Affiliation |
Manipal college of Health Professions, MAHE |
| Address |
Department of Medical Imaging technology, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7204687623 |
| Fax |
|
| Email |
nandini.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka |
| Designation |
Associate professor |
| Affiliation |
Manipal college of Health Professions, MAHE |
| Address |
Department of Medical Imaging technology, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9739314908 |
| Fax |
|
| Email |
priyanka.rao@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka |
| Designation |
Associate professor |
| Affiliation |
Manipal college of Health Professions, MAHE |
| Address |
Department of Medical Imaging technology, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9739314908 |
| Fax |
|
| Email |
priyanka.rao@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Kasturba Hospital, Manipal, Karnataka
Pin code- 576104 |
|
|
Primary Sponsor
|
| Name |
Manipal College of Health Professions |
| Address |
Manipal College of Health Professions, MAHE, Manipal, Karnataka
pin code: 576104 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Rajagopal K V |
Kasturba Hospital, Manipal |
Main CT, ground floor, Department of Radiodiagnosis and imaging, kasturba hospital, Manipal
Udupi
KARNATAKA |
9448158901
rajagopal.kv@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (2) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Pediatric patients who will undergone CECT Chest and CECT Abdomen with age range from 0-18 years
|
|
| ExclusionCriteria |
| Details |
Plain CT Chest and Abdomen, HRCT Thorax, CT KUB, Un co-operative patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study outcomes will be establishing Diagnostic Reference levels and Optimization of radiation dose for CT Chest and Abdomen protocol in pediatric population while maintaining the diagnostic image quality |
Immediately after the scan is completed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to estimate Diagnostic Reference Levels and optimization of dose for Computed tomography of Chest and Abdomen examinations in Pediatric population.The objective of the study is to optimize the radiation dose by using Low dose protocol and compare radiation dose and image quality between standard dose and low dose CT Chest and Abdomen in pediatric population |