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

Cancer, Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03033615
• Other study ID #: ALG-002
• Status: Not yet recruiting
• Phase: N/A
• First received: November 5, 2016
• Last updated: June 26, 2017
• Start date: August 2017
• Est. completion date: December 2017

Study information

• Verified date: June 2017
• Source: AlgoMedica, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Liver
• Cancer, Lung
• Lung Neoplasms
• X-rays; Effects

Intervention

Device:
• PixelShine
Machine learning algorithm
• Conventional processing
Iterative reconstruction software

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
AlgoMedica, Inc.	Cedars-Sinai Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Image Quality as Assessed by Image Noise Reduction	Comparison of image noise	Through study completion, an average of 1 month
Secondary	Image Resolution as Assessed by Size of Detected Lesions	Determine smallest size of detectable objects	Through study completion, an average of 1 month