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

Not Applicable

• Conditions: Cancer Liver; X-rays; Effects; Cancer, Lung
• Interventions: Device: PixelShine; Device: Conventional processing

• Registration Number: NCT03033615
• Lead Sponsor: AlgoMedica, Inc.

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 Timeline

• Study First Submitted: 2016-11-05
• Study First Submitted QC: 2017-01-24
• Study First Posted: 2017-01-27
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-26
• Last Update Posted: 2017-06-28
• Study Start: 2017-08
• Primary Completion: 2017-10
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chest CT	PixelShine	Conventional processing vs. PixelShine processing
Abdominal CT	PixelShine	Conventional processing vs. PixelShine processing
Chest CT	Conventional processing	Conventional processing vs. PixelShine processing
Abdominal CT	Conventional processing	Conventional processing vs. PixelShine processing

Primary Outcome Measures

Name	Time	Method
Visual Image Quality as Assessed by Image Noise Reduction	Through study completion, an average of 1 month	Comparison of image noise

Secondary Outcome Measures

Name	Time	Method
Image Resolution as Assessed by Size of Detected Lesions	Through study completion, an average of 1 month	Determine smallest size of detectable objects