| 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
|
|
|
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
|
|
|
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. |