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

A

AlgoMedica

Status

Unknown

Conditions

Cancer, Lung
Cancer Liver
X-rays; Effects

Treatments

Device: PixelShine
Device: Conventional processing

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03033615
ALG-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups

Chest CT
Active Comparator group
Description:
Conventional processing vs. PixelShine processing
Treatment:
Device: Conventional processing
Device: PixelShine
Abdominal CT
Active Comparator group
Description:
Conventional processing vs. PixelShine processing
Treatment:
Device: Conventional processing
Device: PixelShine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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