Spectral Precise Image Study for Brain Tumors | NCT07620470

Studies
Spectral Precise Image Study for Brain Tumors

NCT07620470

Sponsor

Philips Clinical & Medical Affairs Global

Status

Recruiting

Last Update Posted

Jun 2, 2026Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Brain Tumors

Interventions

This is an observational data collection 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

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 28, 2025Actual

Primary Completion Date

Aug 30, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Nov 24, 2025

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
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to explore the image quality of spectral CT deep learning reconstruction technology (Spectral Precise Image) of patients with confirmed brain tumors.

The main question it aims to answer is:

The Image Quality (IQ) and diagnostic confidence of Spectral Precise Image reconstructions

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Subjective Image quality using Likert score (1-5)	Image quality will be assessed by 2 radiologists using Likert score on a scale ranging from 1(poor) to 5(Excellent)	From date of image reconstruction until the date of image reading completion, anticipated 3Months.
Objective Image Quality	The objective quality of the image is evaluated by measuring the CT value shown in the image.	From date of image reconstruction until the date of image reading completion, anticipated 3Months.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with clinical and radiology (MRI/CT) diagnosed brain tumors.
Patients who underwent contrast enhanced scans using the Spectral CT 7500.
Study participants with age ≥ 18 years old.
Study participants that have signed Informed Consent Form (ICF)

Exclusion Criteria:

The clinical data or radiological information is considered incomplete after evaluation by the investigator.
Study participant that was enrolled in this study in the past
Data from study participants deemed unsuitable for enrollment based on the investigator's evaluation

Accepts Healthy Volunteers

Yes

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

The study population from Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jing Wang	Contact	+8613986085216		xhwangjing@hust.edu.cn

Overall Officials

Name	Affiliation	Role
Jing Wang	1277 Jiefang Avenue, Wuhan, Hubei Province, P. R. China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Recruiting	Wuhan	Hubei		China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001932	Brain Neoplasms

Ancestor Terms

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided