Image Quality Study of Spectral Precise Image CT 7700

Recruiting

• Conditions: Head; Body; Cardiac

• Registration Number: NCT07108205
• Lead Sponsor: Philips Clinical & Medical Affairs Global

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-05-19
• Study Start: 2025-07-16
• Study First Submitted QC: 2025-07-31
• Status Verified: 2025-08
• Study First Posted: 2025-08-06
• Last Update Submitted: 2025-08-13
• Last Update Posted: 2025-08-17
• Primary Completion: 2025-09-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Image Quality (IQ) of Spectral Precise Image reconstructions non inferior to iDose conventional images	0	Primary Endpoint (Co-Primary endpoints): 1. 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.
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).	0	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 Outcome Measures

Name	Time	Method
Evaluation of the differences in Image Quality (IQ) of Spectral Precise Image reconstructions versus iDose conventional images	0	1. 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.
Evaluation of the success rate for Spectral Precise Image reconstruction	0	2. To evaluate the success rate (%) for Spectral Precise Image reconstructions
Evaluation of the interobserver agreement level for the Co-Primary endpoints	0	3. The interobserver agreement level for the Co-Primary endpoints is more than 0.8.
Evaluation of images artifacts visualization and preservation of important features	0	4. Evaluation of images artifacts visualization and preservation of important features and clinical impact on diagnostic ability.

Trial Locations

Locations (3)

Montefiore; 🇺🇸 New York, New York, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Jefferson Einstein; 🇺🇸 Philadelphia, Pennsylvania, United States