NCT07108205

Image Quality Study of Spectral Precise Image CT 7700

Clinical Study for Spectral Precise Image (SPI) Algorithm

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 126 (actual)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head
• Body
• Cardiac

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2025-07-16
• Primary completion: 2025-10-14
• Completion: 2025-10-14
• First posted: 2025-08-06
• Last updated: 2025-12-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study