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
|
|
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
|
|
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. |