Image Quality Study of Spectral Precise Image CT 7700

NCT07108205 | Completed FDA Device

• 1 other identifier: PD-300450
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 3

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.

Conditions

Head; Body; Cardiac

Keywords

CT; Tomography; Image Quality; Noise reduction

Outcome Measures

Primary Outcomes (2)

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

  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.

  1 day

• 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).

  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).

  1 day

Secondary Outcomes (4)

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

  1 day

• Evaluation of the success rate for Spectral Precise Image reconstruction

  1 day

• Evaluation of the interobserver agreement level for the Co-Primary endpoints

  1 day

• Evaluation of images artifacts visualization and preservation of important features

  1 day

Study Arms (2)

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

Device: Paired reading analysis

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

Device: Paired reading analysis

Interventions

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

Raw data will be reconstructed with Spectral Precise Image; Raw data will be reconstructed with iDose4

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Data from subjects that met ALL of the inclusion criteria and NONE of the exclusion criteria will be included in this study

You may qualify if:

• Subjects scanned by Spectral CT (K203020) according to the department standard of care clinical protocols.
• Subjects age \> twenty-two (22) years

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (3)

Montefiore

New York, New York, 10467, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Jefferson Einstein

Philadelphia, Pennsylvania, 19107, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: August 6, 2025
• Study Start: July 16, 2025
• Primary Completion: October 14, 2025
• Study Completion: October 14, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (3)