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CTRI Number  CTRI/2025/10/095784 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On: 07/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To estimate and reduce radiation dose in different abdomen and pelvis CT scans based on indications 
Scientific Title of Study   Estimation of indication-based diagnostic reference level and developing optimized protocols for Abdominopelvic CT 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shivanath Shanbhag 
Designation  Phd scholar 
Affiliation  Manipal College of Health Professions (MCHP), MAHE 
Address  Department of Medical Imaging Technology, Manipal College of Health Professions (MCHP), MAHE

Udupi
KARNATAKA
576107
India 
Phone  7022865042  
Fax    
Email  shivanath.mchpmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Shivanath Shanbhag 
Designation  Phd scholar 
Affiliation  Manipal College of Health Professions (MCHP), MAHE 
Address  Department of Medical Imaging Technology, Manipal College of Health Professions (MCHP), MAHE

Udupi
KARNATAKA
576107
India 
Phone  7022865042  
Fax    
Email  shivanath.mchpmpl2024@learner.manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Nitika C Panakkal 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions (MCHP), MAHE 
Address  Department of Medical Imaging Technology, Manipal College of Health Professions (MCHP), MAHE Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  8861615165  
Fax    
Email  nitika.cp@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Hospital, Madhav Nagar, Near Tiger circle, Manipal - 576104, Karnataka, India 
Manipal College of Health Professions (MCHP),MAHE, Madhav Nagar, Near Tiger circle, Manipal - 576104, Karnataka, India 
 
Primary Sponsor  
Name  Shivanath Shanbhag M 
Address  Manipal College of Health Professions, MAHE, Madhav Nagar,Near Tiger circle, Manipal - 576104, Karnataka, India 
Type of Sponsor  Other [Self] 
 
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 
Dr Prakashini K  Kasturba Hospital, Manipal  Room No 2 Main CT scan,Department of radiodiagnosis and Imaging Kasturba Hospital Manipal, Udupi,Karnataka 576104
Udupi
KARNATAKA 
9845053325

prakashini.k@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K928||Other specified diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Those who are aged 18 years or above will be included.
Multiphase contrast-enhanced CT (CECT) protocols of CT Enterography, CT Pancreatitis, CT Urography, and KUB Follow-up examinations (NCCT).
The BMI range, from underweight to obesity class I, will be recorded for all participants
 
 
ExclusionCriteria 
Details  Patients referred to other multiphase abdominal scans will be excluded.
Patients with a BMI above 30 or those classified as obesity class II are excluded(28).
Cases involving the thorax as part of the abdominal study will be excluded.
Patients who received a different contrast agent, such as Visipaque, will be excluded.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate clinical indication based on DRL for routine CT abdominopelvic CT protocols.   1.5 years 
 
Secondary Outcome  
Outcome  TimePoints 
To develop and optimize clinical indication-based CT protocols in abdominal and pelvic imaging  1.5 years 
 
Target Sample Size   Total Sample Size="352"
Sample Size from India="352" 
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)   22/10/2025 
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 research protocol aims to optimize radiation dose in abdominopelvic CT imaging by establishing clinical indication-based diagnostic reference levels (CIDRLs) rather than traditional anatomy-based DRLs. Conventional DRLs are limited because the same anatomical region can include multiple clinical indications that require different scan phases and exposure levels, leading to variations in patient dose. The study addresses this gap by focusing on four key indications—CT Urography, CT Enterography, CT Pancreas, and CT KUB follow-up—using a 128-slice CT scanner. In Phase 1, indication-specific DRLs will be estimated prospectively from adult patients, with dose metrics (CTDIvol, DLP, ED) and image quality (SNR, CNR, noise, and qualitative scoring) assessed. In Phase 2, optimized protocols will be developed by tailoring scan parameters such as kVp, mAs, scan coverage, and phases based on patient BMI and clinical indication, followed by comparison with baseline protocols to validate improvements. A pilot study indicated that CT Urography delivered the highest radiation dose, highlighting the urgent need for dose reduction. The expected outcomes include institution-specific CIDRLs, optimized abdominopelvic CT protocols, and baseline data for future regional or national studies. Clinically, this work will improve patient safety by reducing unnecessary radiation exposure, enhance diagnostic efficiency, standardize imaging practices, and support regular audits in line with ALARA principles.
 
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