Spectral Precise Image-Colon Cancer | NCT07620444

Studies
Spectral Precise Image-Colon Cancer

NCT07620444

Sponsor

Philips Clinical & Medical Affairs Global

Status

Not yet recruiting

Last Update Posted

Jun 2, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Colon Cancer Patients

Interventions

This is an observational study

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2026Estimated

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

May 11, 2026

First Submission Date that Met QC Criteria

May 27, 2026

First Posted Date

Jun 2, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2026

Last Update Posted Date

Jun 2, 2026Actual

Name	Class
Sun Yat-Sen University Cancer Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a single-center, comparative, observational study. Datasets will be collected from patients with pathologically confirmed colon cancer who undergo abdomen-pelvis enhanced spectral CT scan.

Detailed Description

This is a single-center, comparative, observational study. Datasets will be collected from patients with pathologically confirmed colon cancer who undergo abdomen-pelvis enhanced spectral CT scan at investigational center, including retrospective and prospective data. Based on the Dose Right Index (DRI) derived from CT image data, relevant data will be collected at a 1:1 ratio for the conventional radiation dose group (RD group, DRI = 21) and the low radiation dose group (LD group, DRI = 18). A total of 100 cases of datasets is expected to be collected. All CT raw data will be transmitted to Philips after the completion of the de-identification process. For the three-phase data of the LD group (plain scan, arterial phase and venous phase), offline reconstruction will be performed using the Spectral Precise Image algorithm to generate conventional images and VMI-40 keV images. A total of six image sequences will be quantitatively and qualitatively evaluated and compared. For both groups, conventional images and VMI-40 keV images will be reconstructed using iDose4.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
This is an observational study	Device	This is an observational study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
subjective overall Image quality using 5-point Likert scale(1-5)	Radiologist will evaluate the overall image quality using 5 Likert scale ranging from 1(poor) to 5 (Excellent)	From the date of image reconstruction completion to the date of image evaluation completion, anticipated 3 Months.
Objective image quality	The objective image quality is evaluated by measuring the CT value shown in the image.	From the date reconstruction completion to the date of image evaluation completion, anticipated 3months.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients pathologically confirmed with colon cancer via endoscopic biopsy.
Patients who underwent preoperative abdominopelvic enhanced spectral CT.
Study participant with age ≥ 18 years old.
Study participants that have signed Informed Consent Form (ICF).

Exclusion Criteria:

The clinical data or pathological information is considered incomplete after evaluation by the investigator.
The investigator determined that poor image quality (e.g. obvious artifacts, missing critical scan layers) would not satisfy post-processing analysis.
Data of patients deemed inappropriate for inclusion after evaluation by the investigator.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with colon cancer aged 18.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Miao Chuan Xie	Contact	+8618903050011		xiechm@sysucc.org.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat-sen cancer center		Guangzhou	Guangdong		China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Site and Sponsor need further discussion

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided