Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-31 @ 7:16 PM
Study NCT ID:
NCT07108205
Status:
COMPLETED
Last Update Posted:
2025-12-15
First Post:
2025-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Image Quality Study of Spectral Precise Image CT 7700
Sponsor:
Philips Clinical & Medical Affairs Global
Organization:
Study Overview
Official Title:
Clinical Study for Spectral Precise Image (SPI) Algorithm
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: