Image Quality Study of Spectral Precise Image CT 7700

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

COMPLETED

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-16

Study Completion Date

2025-10-14

Brief Summary

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The goal of the study is to evaluate the Image Quality (IQ), and diagnostic confidence of Spectral Precise Image for CT 7700 Scanner as compared with iDose4 as a standard-of-care reference.

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Detailed Description

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Spectral Precise Image is a reconstruction technique where the system uses a trained deep learning neural network to produce an image that reduces noise while improving low contrast detectability and maintaining the appearance of traditional filtered back projection (FBP) images.

Spectral Precise Image in Spectral CT 7700 system supports both conventional and spectral reconstructions.

The study will use raw data of subjects that are over the age of 22 years and scanned by Philips Spectral CT.

Study raw data, following anonymization, will be transferred to Philips for reconstructions, both conventional and spectral images will be reconstructed with iDose4 and with Spectral Precise Image at 100% dose.

Conditions

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Head Body Cardiac

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Raw data will be reconstructed with iDose4

Raw data of subjects included in the study, following anonymization, will be transferred to Philips for reconstruction, raw data will be reconstructed with iDose4

Paired reading analysis

Intervention Type DEVICE

Paired side be side evaluation Each reader will assess- Image Quality (IQ) \& Diagnostic Confidence Ratings will be recorded using a 5-point Likert scale

Raw data will be reconstructed with Spectral Precise Image

Raw data of subjects included in the study, following anonymization, will be transferred to Philips for reconstruction, raw data will be reconstructed with Spectral Precise Image

Paired reading analysis

Intervention Type DEVICE

Paired side be side evaluation Each reader will assess- Image Quality (IQ) \& Diagnostic Confidence Ratings will be recorded using a 5-point Likert scale

Interventions

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Paired reading analysis

Paired side be side evaluation Each reader will assess- Image Quality (IQ) \& Diagnostic Confidence Ratings will be recorded using a 5-point Likert scale

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* • Subjects scanned by Spectral CT (K203020) according to the department standard of care clinical protocols.

* Subjects age \> twenty-two (22) years

Exclusion Criteria

* • Scans that the site radiologists have deemed as non-diagnostic image quality in the standard practice (e.g. patient movement)

* Scans that are not completed due to technical difficulties

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No