Improving Brain and Chest Imaging Enhancing Clarity and Reducing Radiation with Deep Learning Technology

Phase 1

Recruiting

Conditions: Adult patients from age of 18years to 90years who are recommended to undertake CT Brain and Thorax scans

Registration Number: CTRI/2023/07/055310

Lead Sponsor: Kasturba Medical College Manipal

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 â€œAs Low As Reasonably Achievableâ€ 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 313

Inclusion Criteria

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.

Exclusion Criteria

Patients who are un-cooperative, Patients who are allergic to contrast media, Patients with High BMI, Patients with high creatine and urea level.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (1): Kasturba Hospital Manipal
🇮🇳
Udupi, KARNATAKA, India
Kasturba Hospital Manipal
🇮🇳Udupi, KARNATAKA, India
Mr Obhuli Chandran M
Principal investigator
9445882423
obhuli.mchpmpl2022@learner.manipal.edu