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

NCT ID: NCT03033615

Last Updated: 2017-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-31

Study Completion Date

2017-12-31

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.

Conditions

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Cancer, Lung Cancer Liver X-rays; Effects

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Chest CT

Conventional processing vs. PixelShine processing

Group Type ACTIVE_COMPARATOR

PixelShine

Intervention Type DEVICE

Machine learning algorithm

Conventional processing

Intervention Type DEVICE

Iterative reconstruction software

Abdominal CT

Conventional processing vs. PixelShine processing

Group Type ACTIVE_COMPARATOR

PixelShine

Intervention Type DEVICE

Machine learning algorithm

Conventional processing

Intervention Type DEVICE

Iterative reconstruction software

Interventions

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PixelShine

Machine learning algorithm

Intervention Type DEVICE

Conventional processing

Iterative reconstruction software

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role collaborator

AlgoMedica, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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ALG-002

Identifier Type: -

Identifier Source: org_study_id

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