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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- AlgoMedica, Inc.
- Enrollment
- 20
- Primary Endpoint
- Visual Image Quality as Assessed by Image Noise Reduction
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Abdominal CT
Conventional processing vs. PixelShine processing
Intervention: PixelShine (Device)
Chest CT
Conventional processing vs. PixelShine processing
Intervention: Conventional processing (Device)
Chest CT
Conventional processing vs. PixelShine processing
Intervention: PixelShine (Device)
Abdominal CT
Conventional processing vs. PixelShine processing
Intervention: Conventional processing (Device)
Outcomes
Primary Outcomes
Visual Image Quality as Assessed by Image Noise Reduction
Time Frame: Through study completion, an average of 1 month
Comparison of image noise
Secondary Outcomes
- Image Resolution as Assessed by Size of Detected Lesions(Through study completion, an average of 1 month)