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CTRI Number  CTRI/2024/03/064056 [Registered on: 13/03/2024] Trial Registered Prospectively
Last Modified On: 30/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparison of image quality between idose4 and precise image for low-dose CT of the abdomen and pelvis among low B.M.I individuals 
Scientific Title of Study   Comparison of image quality between hybrid iterative reconstruction and deep learning image reconstruction for low-dose CT of the abdomen and pelvis among low B.M.I individuals 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abraham Jacob 
Designation  MSc student 
Affiliation  Manipal college of health professions MAHE Manipal 
Address  Department of Medical Imaging Technology Manipal college of health professions MAHE Manipal 576104

Udupi
KARNATAKA
576104
India 
Phone  9843530612  
Fax    
Email  abraham.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Abraham Jacob 
Designation  MSc student 
Affiliation  Manipal college of health professions MAHE Manipal 
Address  Department of Medical Imaging Technology Manipal college of health professions MAHE Manipal 576104

Udupi
KARNATAKA
576104
India 
Phone  9843530612  
Fax    
Email  abraham.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Public Query  
Name  Ms Nitika C Panakkal 
Designation  assistant professor selection grade 
Affiliation  Manipal college of health professions MAHE Manipal 
Address  Department of Medical Imaging Technology Manipal college of health professions MAHE Manipal 576104

Udupi
KARNATAKA
576104
India 
Phone  8861615165  
Fax    
Email  nitika.cp@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Hospital, Manipal 
 
Primary Sponsor  
Name  Kasturba Hospital 
Address  Manipal Udupi Karnataka 576104 
Type of Sponsor  Research institution and hospital 
 
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 Rajagopal K V  Kasturba hospital  Room no 2 Main CT scan Department of Radio diagnosis and imaging
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R935||Abnormal findings on diagnostic imaging of other abdominal regions, including retroperitoneum, (2) ICD-10 Condition: R933||Abnormal findings on diagnostic imaging of other parts of digestive tract, (3) ICD-10 Condition: R932||Abnormal findings on diagnostic imaging of liver and biliary tract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients who are of age above 18 years, referred for CECT abdomen.
Low Body Mass Index population (less than 18.5 kg/m²)
 
 
ExclusionCriteria 
Details  Patients who come above 18.5 kg/m2 Body mass index Population.
Uncooperative patients.
Fatty, liver cirrhosis patients will be excluded
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Signal-to-Noise Ratio (SNR), Contrast-to-Noise Ratio (CNR), and image noise  16 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/03/2024 
Date of Study Completion (India) 17/01/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 17/01/2025 
Estimated Duration of Trial   Years="1"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Informed consent and 50 participants will be taken for the study. 
The patients age, height and weight will be measured, and their body mass index (BMI) will be calculated. The scan will be acquired using the standard protocol used for CECT abdomen and pelvis which is the standard of care for all low BMI patients and no additional costs will be borne by the patients. The acquired data will then undergo reconstruction using idose4 and precise imaging techniques. The quantitative assessment of image quality will be performed by calculating signal-to-noise ration (SNR), contrast-to-noise ratio (CNR), and image noise. data analysis will be performed, and outcome measures will be drawn.
 
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