PixelShine vs. Iterative Reconstruction (IR) Processing of CT Images

Study Overview
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Brief Summary
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This study will compare the quality of CT images acquired with very low-dose radiation and processed with commercially available software vs. PixelShine processed images. It would potentially allow imaging facilities to acquire CT scans using lower doses of radiation without sacrificing clarity of CT images. Acquiring high quality CT images with low-dose radiation has the potential to enhance patient safety and has significant implications in imaging practices.

Detailed Description
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Patients receiving CT scans as part of their standard treatment will be asked to consent to an additional 5 minutes of imaging using very low-dose radiation prior to the conventional-dose CT scan. The prospective review will be performed in two cohorts: Chest CT scans and abdominal CT scans. Anonymized images will be processed by conventional CT software and compared to the same images processed with machine-learning-based PixelShine. A board-certified radiologist will assess the noise and visual quality of the imaging data. Study patients will receive approximately 10% more dose than a standard CT scan by participating in the study. There are no known short-term safety issues associated with this study. The study-related very low dose radiation is at a level far below that used for conventional x-ray imaging. The study has been approved by the Radiation Safety Committee as part of the review process.

Official Title
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Prospective Review of CT Imaging Data Comparing Quality of Low-Radiation-Dose Images Post-Processed With Iterative Reconstruction Software vs. Machine Learning (AlgoMedica PixelShine) Software

Conditions
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Cancer, Lung, Cancer Liver, X-rays; Effects

Intervention / Treatment
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* Device: PixelShine
* Device: Conventional processing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be 18 years of age or older Patients must be able and willing to consent to participate in this project Patients will be scheduled for a standard of care CT scan Exclusion Criteria: This study does not investigate either a specific disease or a specific patient population-it only examines and compares images obtained at low radiation exposure post-processed with Algomedica's PixelShine software with conventionally processed images All other patients will be excluded

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chest CT<br>Conventional processing vs. PixelShine processing | Device: PixelShine<br>* Machine learning algorithm<br>Device: Conventional processing<br>* Iterative reconstruction software<br>|
| Active Comparator: Abdominal CT<br>Conventional processing vs. PixelShine processing | Device: PixelShine<br>* Machine learning algorithm<br>Device: Conventional processing<br>* Iterative reconstruction software<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Image Quality as Assessed by Image Noise Reduction | Comparison of image noise | Through study completion, an average of 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image Resolution as Assessed by Size of Detected Lesions | Determine smallest size of detectable objects | Through study completion, an average of 1 month |