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CTRI Number  CTRI/2024/03/064671 [Registered on: 22/03/2024] Trial Registered Prospectively
Last Modified On: 21/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Classification of Non-Small Lung Carcinoma Using Ai based algorithm 
Scientific Title of Study   Classification of Non-small Cell Lung Carcinoma Using Machine Learning Methods Based on CT Radiomic Features  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kaushik Nayak 
Designation  Assistant Professor 
Affiliation  Kasturba medical College and Hospital 
Address  Room No. 404 Department of Medical Imaging Technology MCHP - Manipal College of Health Professions Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone  9113933708  
Fax    
Email  nayak.kaushik@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr. Rajagopal K V  
Designation  Professor 
Affiliation  Kasturba medical College and Hospital 
Address  Room No. 1 Department of Radiodiagnosis and Imaging Kasturba Medical College and Hospital Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone  9113933708  
Fax    
Email  rajagopal.kv@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Kaushik Nayak 
Designation  Assistant Professor 
Affiliation  Kasturba medical College and Hospital 
Address  Room No.404 Department of Medical Imaging Technology MCHP - Manipal College of Health Professions Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone  9113933708  
Fax    
Email  nayak.kaushik@manipal.edu  
 
Source of Monetary or Material Support  
Room No.3 Department of Radiodiagnosis and Imaging Kasturba Medical College and Hospital, MAHE, Manipal 
 
Primary Sponsor  
Name  Department of Radiodiagnosis and Imaging 
Address  Kasturba Medical College and Hospital 
Type of Sponsor  Research institution 
 
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 Medical College and Hospital  Room No.3 Department of Radiodiagnosis and Imaging, Kasturba Medical College and Hospital MAHE, Manipal
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 Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J984||Other disorders of lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients with CT imaging features of Squamous cell carcinoma and Adenocarcinoma.
 
 
ExclusionCriteria 
Details  Patients with histopathologic diagnosis of small cell carcinoma 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The machine learning methods based on CT radiomic features can be used to classify Non-Small Cell Lung Carcinoma subtypes using a simple, non-invasive, and cost-effective diagnostic approach
 		 Scan will be performed after biopsy 
 
Secondary Outcome  
Outcome  TimePoints 
Machine learning methods based on CT radiomic features can provide non-invasive diagnosis of classification of Non-Small Cell Lung Carcinoma.
 		 scan will be performed after biopsy 
 
Target Sample Size   Total Sample Size="114"
Sample Size from India="114" 
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)   31/03/2024 
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="4"
Days="5" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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     57  of Squamous Cell carcinoma and Adenocarcinoma will be included in the study. Patients with CT imaging Characteristics of Squamous Cell Carcinoma and Adenocarcinoma will be selected for the study. Data will be collected from patients undergoing CT Contrast Thorax considering inclusion and exclusion criteria using convenience sampling technique. Post contrast images will be acquired using Philips Incisive 128 slice Ct and Philips Brilliance 16 Slice Big Bore CT (Philips Health Care) will be used for extracting the radiomic features from the tumor volume. Machine learning models will be are validated using prospective data.   
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