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

Primary Purpose

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

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

PixelShine

Conventional processing

About this trial

This is an interventional diagnostic trial for Cancer, Lung

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Chest CT

Abdominal CT

Arm Description

Conventional processing vs. PixelShine processing

Outcomes

Primary Outcome Measures

Visual Image Quality as Assessed by Image Noise Reduction

Comparison of image noise

Secondary Outcome Measures

Image Resolution as Assessed by Size of Detected Lesions

Determine smallest size of detectable objects

Full Information

NCT ID

NCT03033615

First Posted

November 5, 2016

Last Updated

June 26, 2017

Sponsor

AlgoMedica, Inc.

Collaborators

Cedars-Sinai Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03033615

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

August 2017 (Anticipated)

Primary Completion Date

October 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AlgoMedica, Inc.

Collaborators

Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chest CT

Arm Type

Active Comparator

Arm Description

Conventional processing vs. PixelShine processing

Arm Title

Abdominal CT

Arm Type

Active Comparator

Arm Description

Conventional processing vs. PixelShine processing

Intervention Type

Device

Intervention Name(s)

PixelShine

Intervention Description

Machine learning algorithm

Intervention Type

Device

Intervention Name(s)

Conventional processing

Intervention Description

Iterative reconstruction software

Primary Outcome Measure Information:

Title

Visual Image Quality as Assessed by Image Noise Reduction

Description

Comparison of image noise

Time Frame

Through study completion, an average of 1 month

Secondary Outcome Measure Information:

Title

Image Resolution as Assessed by Size of Detected Lesions

Description

Determine smallest size of detectable objects

Time Frame

Through study completion, an average of 1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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