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CTRI Number  CTRI/2025/10/096116 [Registered on: 15/10/2025] Trial Registered Prospectively
Last Modified On: 09/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   How Body Size Affects Liver Imaging and Contrast volume in Abdominal CT Scans 
Scientific Title of Study   Influence of body habitus on hepatic enhancement and contrast media dose optimization in abdominopelvic CT: A Prospective Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jyoti Garg 
Designation  PhD Research Scholar 
Affiliation  Manipal College of Health Professions (MCHP), MAHE  
Address  Department of Medical Imaging Technology, Manipal College of Health Professions (MCHP), MAHE

Udupi
KARNATAKA
576104
India 
Phone  9350362874  
Fax    
Email  jyoti.mchpmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Jyoti Garg 
Designation  PhD Research Scholar 
Affiliation  Manipal College of Health Professions (MCHP), MAHE  
Address  Department of Medical Imaging Technology, Manipal College of Health Professions (MCHP), MAHE

Udupi
KARNATAKA
576104
India 
Phone  9350362874  
Fax    
Email  jyoti.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

Udupi
KARNATAKA
576104
India 
Phone  8861615165  
Fax    
Email  nitika.cp@manipal.edu   
 
Source of Monetary or Material Support  
Kasturba Hospital, Manipal, Karnataka, India 576104 
Manipal College of Health Professions (MCHP),MAHE, Manipal, Karnataka, India 576104 
 
Primary Sponsor  
Name  Jyoti Garg 
Address  Department of Medical Imaging Technology, Manipal College of Health Professions (MCHP), MAHE, Manipal, Karnataka, India 576104  
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 Rajagopal Kadavigere  Kasturba Hospital  Room No 2 Main CT Scan Department of radio Diagnosis and Imaging Kasturba Hospital Manipal
Udupi
KARNATAKA 		 9448158901

rajarad@gmail.com 
 
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: K929||Disease of digestive system, unspecified,  
 
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.
Low and Normal BMI patients
and Patient receiving only Iohexol contrast of concentration 300 mgI/ml 
 
ExclusionCriteria 
Details  Trauma & Emergency cases
Patients with conditions such as liver cirrhosis, severe fatty liver, as assessed through USG
reports, which can change the density of the organs.
Pathologies such as hepatocellular carcinoma (HCC) requiring higher contrast volumes.
Patients with an allergy to iodinated contrast
Patients with High creatinine level
Patients with high BMI  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the correlation between body size parameters (TBW, LBW, BSA, FFM, AFR) and hepatic enhancement, and to evaluate image quality (quantitative and qualitative) in low- and normal-BMI groups at 80 and 100 kVp.  1.5 years  
 
Secondary Outcome  
Outcome  TimePoints 
To develop an optimized contrast dosing protocol based on the most predictive body size parameter and compare liver enhancement and image quality before and after optimization.  1.5 years  
 
Target Sample Size   Total Sample Size="256"
Sample Size from India="256" 
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)   10/11/2025 
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   The study aims to evaluate the influence of body habitus on liver enhancement and contrast dose optimization in abdominal CT. It will be conducted in two phases. In Phase 1, patients with low and normal BMI will undergo CT scans at 80 and 100 kVp using a fixed contrast dose to assess the correlation between body size parameters such as total body weight, lean body weight, body surface area, fat-free mass, and abdominal fat ratio with hepatic enhancement and image quality. In Phase 2, the most predictive body size parameter identified in Phase 1 will be used to individualize and optimize the contrast dose. The optimized protocol will then be compared with the standard fixed-dose protocol. The main outcome measures will include liver enhancement in Hounsfield units, contrast to noise ratio, and qualitative image quality scores. 
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