Validation of Whole Body PET/CT Foundation Model | NCT07196995

Studies
Validation of Whole Body PET/CT Foundation Model

NCT07196995

Sponsor

Shanghai 6th People's Hospital

Status

Not yet recruiting

Last Update Posted

Oct 3, 2025Actual

Enrollment

180Estimated

Phase

Not provided

Conditions

Bone Metastases

Interventions

Not provided

Countries

Not provided

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

Sep 2025

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

Oct 16, 2025Estimated

Primary Completion Date

Sep 15, 2026Estimated

Completion Date

Dec 15, 2026Estimated

First Submitted Date

Sep 20, 2025

First Submission Date that Met QC Criteria

Sep 20, 2025

First Posted Date

Sep 29, 2025Actual

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

Sep 29, 2025

Last Update Posted Date

Oct 3, 2025Actual

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

Prospective multicenter study to validate the diagnostic performance of whole body PET/CT foundation model for bone lesion detection

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

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group PET/CT		Whole body PET/CT foundation model
Group CT		Whole body CT foundation model

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic performance (benign or malignant)	Patient based bone lesion diagnostic performance (benign or malignant)	At diagnosis time

Secondary Outcomes

Measure	Description	Time Frame
Diagnostic performance (primary or metastases)	Patient based bone lesion diagnostic performance (primary or metastases)	At diagnosis time
Pathology prediction	Pathology prediction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

With suspicious lesion in the bone or with elevated serum tumor markers or patient insist
Over 18 years

Exclusion Criteria:

Active infection at or adjacent to the puncture site
Severe coagulation disorders that cannot be corrected
Random blood glucose > 11.1 mmol/L
Refuse for pathological confirmation or follow-up
Extremely debilitated patients or those unable to cooperate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

With suspicious lesion in the bone

Sampling Method

Probability Sample