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CTRI Number  CTRI/2025/04/084777 [Registered on: 15/04/2025] Trial Registered Prospectively
Last Modified On: 11/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Evaluation of an AI-Powered Tool to Detect Artifacts in CT Scans for Improved Medical Imaging Quality 
Scientific Title of Study   Image Enhancement Assistant: Create a user-friendly tool that employs AI algorithms to Automatically Identify artifacts in CT Scans 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Seetha Rashi 
Designation  Post Graduate  
Affiliation  Saveetha medical college and hospital, Saveetha institute of medical and technical sciences 
Address  Room no.50, Department of radiology, Saveetha medical college and hospital, Saveetha institute of medical and technical sciences,Saveetha nagar, Thandalam, Chennai, India

Chennai
TAMIL NADU
602105
India 
Phone  9515675795  
Fax    
Email  rashiseetha97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrSukumar Ramaswamy 
Designation  Professor 
Affiliation  Saveetha medical college and hospital, Saveetha institute of medical and technical sciences 
Address  Room no.50, Department of radiology, Saveetha medical college and hospital, Saveetha institute of medical and technical sciences,Saveetha nagar, Thandalam, Chennai, India

Chennai
TAMIL NADU
602105
India 
Phone  9841205597  
Fax    
Email  drrsukumar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Seetha Rashi 
Designation  Post Graduate  
Affiliation  Saveetha medical college and hospital, Saveetha institute of medical and technical sciences 
Address  Room no.50, Department of radiology, Saveetha medical college and hospital, Saveetha institute of medical and technical sciences,Saveetha nagar, Thandalam, Chennai, India

Chennai
TAMIL NADU
602105
India 
Phone  9515675795  
Fax    
Email  rashiseetha97@gmail.com  
 
Source of Monetary or Material Support  
Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai-602105 
 
Primary Sponsor  
Name  Dr.Seetha Rashi 
Address  Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai-602105 
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 
DrSeetha Rashi  Saveetha Medical College Hospital  Room no 50, Department of Radiology, Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai. Chennai TAMIL NADU
Chennai
TAMIL NADU 		 9515675795

rashiseetha97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College and 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: R50-R69||General symptoms and signs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Patients referred for CT scans of any anatomical region (e.g., thorax, abdomen, brain) for diagnostic evaluation.
2.Patients who provide written informed consent to participate in the study.
3.Individuals whose medical condition requires CT imaging for diagnosis, treatment planning, or follow-up.
4.Patients whose CT scans need to be evaluated for potential artifacts affecting diagnostic quality.
5.Patients who are clinically stable and can participate without immediate life-threatening conditions.
 
 
ExclusionCriteria 
Details  1.Patients unable or unwilling to provide informed written consent.
2.Patients with critical or life-threatening conditions that require immediate intervention, making participation in the trial unfeasible.
3.Pregnant individuals to avoid potential risks or confounding factors.
4.Scans that are too degraded or incomplete for the app to process effectively.
5.Patients whose CT scans have already been flagged and addressed for artifacts prior to the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the accuracy, sensitivity, and specificity of the AI-powered Image Enhancement Assistant in detecting and identifying artifacts in CT scans to improve diagnostic quality  At baseline, 4 weeks, and 8 weeks post-intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the impact of the AI-powered Image Enhancement Assistant on clinical workflow efficiency and decision-making by reducing the time taken for image quality assessment and the number of repeat scans required.  within 24 hours 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   30/04/2025 
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="1"
Months="6"
Days="0" 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rashiseetha97@gmail.com].

  6. For how long will this data be available start date provided 10-01-2025 and end date provided 31-01-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This clinical trial evaluates the effectiveness of the AI-powered Image Enhancement Assistant, a novel tool designed to detect and address artifacts in CT scans. The assistant leverages advanced AI algorithms to identify common image quality issues such as noise, motion blur, and streak artifacts, ensuring improved diagnostic accuracy and reducing the need for repeat scans.

The trial aims to measure the tool’s accuracy (sensitivity and specificity) in artifact detection and its impact on clinical workflow efficiency, including time saved and reduction in diagnostic errors. By integrating seamlessly into existing medical imaging workflows, the Image Enhancement Assistant promises to enhance patient care, optimize resource utilization, and improve overall healthcare outcomes. The findings from this trial will contribute to validating the utility of AI-driven tools in modern diagnostic imaging.

 
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