PixelShine vs. Iterative Reconstruction (IR) Processing of CT Images
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
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2017
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2016
CompletedFirst Posted
Study publicly available on registry
January 27, 2017
CompletedStudy Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJune 28, 2017
June 1, 2017
2 months
November 5, 2016
June 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Visual Image Quality as Assessed by Image Noise Reduction
Comparison of image noise
Through study completion, an average of 1 month
Secondary Outcomes (1)
Image Resolution as Assessed by Size of Detected Lesions
Through study completion, an average of 1 month
Study Arms (2)
Chest CT
ACTIVE COMPARATORConventional processing vs. PixelShine processing
Abdominal CT
ACTIVE COMPARATORConventional processing vs. PixelShine processing
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AlgoMedica, Inc.lead
- Cedars-Sinai Medical Centercollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2016
First Posted
January 27, 2017
Study Start
August 1, 2017
Primary Completion
October 1, 2017
Study Completion
December 1, 2017
Last Updated
June 28, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share