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CTRI Number  CTRI/2023/07/055310 [Registered on: 18/07/2023] Trial Registered Prospectively
Last Modified On: 09/09/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Improving Brain and Chest Imaging Enhancing Clarity and Reducing Radiation with Deep Learning Technology 
Scientific Title of Study   Comparision of Deep Learning Reconstruction and Iterative Reconstruction Algorithm for Reducing Radiation Dose in CT Brain and Thorax 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Obhuli Chandran M 
Designation  Dr. TMA Pai PhD Research Scholar  
Affiliation  Manipal College of Health Professions/Manipal Academy of Higher Education 
Address  Department of Medical Imaging Technology, Manipal College of Health Professions, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9445882423  
Fax    
Email  obhuli.mchpmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Saikiran P 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions/Manipal Academy of Higher Education 
Address  Department of Medical Imaging Technology, Manipal College of Health Professions, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8320126806  
Fax    
Email  saikiran.p@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Rajagopal KV 
Designation  Professor  
Affiliation  Kasturba Medical College/Manipal Academy of Higher Education 
Address  Department of Radio-diagnosis and Imaging, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448158901  
Fax    
Email  rajarad@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104 
 
Primary Sponsor  
Name  Kasturba Medical College Manipal 
Address  Department of Medical Imaging Technology, Manipal College of Health Professions, Manipal 
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 
Mr Obhuli Chandran M  Kasturba Hospital Manipal  Department of Radio-diagnosis and Imaging, Kasturba Medical College, Manipal
Udupi
KARNATAKA 
9445882423

obhuli.mchpmpl2022@learner.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 
Healthy Human Volunteers  Adult patients from age of 18years to 90years who are recommended to undertake CT Brain and Thorax scans 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Low Dose Protocol using Deep Learning Reconstruction Algorithm  The patients who are referred for CT Brain, CECT Brain, CECT Thorax and HRCT Thorax will be undergoing the low dose settings with Deep Learning Reconstruction Algorithm with radiation dose factor of kVp 100 and 200mAs for CT Brain and CECT Brain. The CECT Brain contrast dose administered will be 25ml. The patients undergoing CT Thorax and HRCT Thorax will be undergoing kVp 100 and mAs 40 with reduced contrast dosr of 30ml for CECT scans. The contrast injection will be administered intravenously.  
Comparator Agent  Standard Dose Protocol with Iterative Reconstruction Algorithm  The patients who are referred for CT Brain, CECT Brain, CECT Thorax and HRCT Thorax will be undergoing the standard dose settings with iterative reconstruction algorithm with radiation dose factor of kVp 120 and 390mAs for CT Brain and CECT Brain. The CECT Brain contrast dose administered will be 50ml through intravenously. The CECT Thorax and HRCT Thorax scans will be done using standard radiation dose factors of kVp 120 and mAs 110. CECT Thorax contrast dose of 60ml will be administered intravenously. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients who are referred to CT Brain, CECT Brain, CECT Thorax, and HRCT Thorax by the registered physician will be included in this study with valid informed consent and the procedure explained. 
 
ExclusionCriteria 
Details  Patients who are un-cooperative, Patients who are allergic to contrast media, Patients with High BMI, Patients with high creatine and urea level. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the radiation dose and image quality of 313 sample size which includes (CT Brain- 96, CECT Brain- 59, CECT Thorax - 72, HRCT Thorax - 86) standard dose and contrast volume protocol done with Iterative reconstruction algorithm for CT Brain Plain, CECT Brain, CECT Thorax and HRCT Thorax.  1 years from the date of starting the study 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the image quality & radiation dose of 313 samples which includes ( CT Brain- 96, CECT Brain - 59, CECT Thorax- 72, HRCT Thorax - 86)low dose & low contrast volume protocol with deep learning reconstruction algorithm with standard dose protocol iterative reconstruction algorithm for CT Brain Plain, CECT Brain, CECT Thorax & HRCT Thorax.  1 year from completion of Phase I. 
 
Target Sample Size   Total Sample Size="313"
Sample Size from India="313" 
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   Phase 1 
Date of First Enrollment (India)   31/07/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

CT is the prime modality for diagnosis, treatment efficacy evaluation, and follow-up for brain and thorax pathologies which involves higher radiation and increases the risk of cancers. Optimization of radiation dose and contrast volume for CT Brain and Thorax examination is important for reducing the radiation and reducing the risk of Contrast-Induced Nephropathy (CIN) who requires follow-up contrast-enhanced CT. There are limited studies that evaluated the radiation dose and image quality of low dose and low contrast volume protocol for CT Brain and Thorax using the Deep Learning Based Reconstruction (DLR) algorithm. There are limited studies that compared the radiation dose and image quality for CT Brain and Thorax between iDose4 and Deep Learning Reconstruction (DLR) algorithm. This study consists of Phase I and Phase 2. Phase I of the study will be done for the patient who are referred for CT Brain Plain, CECT Brain, CECT Thorax and HRCT Thorax using standard dose settings. Qualitative analysis will be performed by two radiologists using five-pint likert scale for overall image quality, subjective noise and artefacts. The quantitative analysis will be performed by evaluating Signal to Noise Ratio, Contrast to Noise Ratio and Hounsfield Unit. The radiation dose information such as CTDIvol, Dose Length Product and Size Specific Dose Estimate will be noted from the console for each scans. The Phase II Low-dose protocol will be developed by scanning the Head and Body phantom with 100 kVp and different mAs settings (CT Brain Plain, CECT Brain 100-200 mAs, CECT Thorax and HRCT Thorax 20-40 mAs). For CT Brain, the optimum parameters were noted as 100 kVp and 200 mAs, which produced optimum image quality and reduced radiation dose. For CT Thorax, the optimum parameters were noted as 100 kVp and 40 mAs with optimum image quality and reduced radiation dose. Scanning will be performed using the low dose protocol in patients referred for CT Brain Plain, CECT Brain, CECT Thorax and HRCT Thorax (Table 2). The low-dose images will be reconstructed with deep learning reconstruction (DLR) algorithm . For CT Brain Plain, CECT Brain, CECT Thorax and HRCT Thorax the scan will be performed with a reduced volume of 30 ml and 40ml respectively. Qualitative analysis will be performed by two radiologists using five-pint likert scale for overall image quality, subjective noise and artefacts. The quantitative analysis will be performed by evaluating Signal to Noise Ratio, Contrast to Noise Ratio and Hounsfield Unit. The radiation dose information such as CTDIvol, Dose Length Product and Size Specific Dose Estimate will be noted from the console for each scans. The study is directly beneficial as it aims to reduce dose during the study “As Low As Reasonably Achievable” and uses low volume of contrast medium reducing chances of its adverse effect. The studies have shown good image quality, reduced CTDI and diagnostic accuracy with it. 

 
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