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Completed

NCT Number: NCT07108205

Image Quality Study of Spectral Precise Image CT 7700

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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Key information

Conditions

Head Body Cardiac

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Montefiore, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paired reading analysis

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

Primary outcomes

  1. Image Quality (IQ) of Spectral Precise Image reconstructions non inferior to iDose conventional images

    Time frame: 1 day

    Primary Endpoint (Co-Primary endpoints):

    • The Image Quality (IQ) and diagnostic confidence of Spectral Precise Image reconstructions is at least as good as (non-inferior to) iDose4 for conventional images.

  2. Image Quality (IQ) of Spectral Precise Image reconstructions non-inferior to iDose4 for spectral images of MonoE (MonoE 70Kev for Cardiac and for Body/ MonoE 66KeV for Head).

    Time frame: 1 day

    Primary Endpoint (Co-Primary endpoints): 2. The Image Quality (IQ) and diagnostic confidence of Spectral Precise Image reconstructions is at least as good as (non-inferior to)-iDose4 for spectral images of MonoE (MonoE 70Kev for Cardiac and for Body/ MonoE 66KeV for Head).

Secondary outcomes

  1. Evaluation of the differences in Image Quality (IQ) of Spectral Precise Image reconstructions versus iDose conventional images

    Time frame: 1 day

    • To evaluate the difference in Image Quality (IQ) and diagnostic confidence between Spectral Precise Image reconstructions for spectral images of MonoE (MonoE 70Kev for Cardiac and for Body/ MonoE 66KeV for Head) and iDose4 for conventional images.

  2. Evaluation of the success rate for Spectral Precise Image reconstruction

    Time frame: 1 day

    • To evaluate the success rate (%) for Spectral Precise Image reconstructions

  3. Evaluation of the interobserver agreement level for the Co-Primary endpoints

    Time frame: 1 day

    • The interobserver agreement level for the Co-Primary endpoints is more than 0.8.

  4. Evaluation of images artifacts visualization and preservation of important features

    Time frame: 1 day

    • Evaluation of images artifacts visualization and preservation of important features and clinical impact on diagnostic ability.

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Registry information

Official study title

Clinical Study for Spectral Precise Image (SPI) Algorithm

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 6, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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