Validation of Whole Body PET/CT Foundation Model

Not yet recruiting

• Conditions: Bone Metastases

• Registration Number: NCT07196995
• Lead Sponsor: Shanghai 6th People's Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-20
• Study First Submitted QC: 2025-09-20
• Study First Posted: 2025-09-29
• Last Update Submitted: 2025-09-29
• Last Update Posted: 2025-10-03
• Study Start: 2025-10-16
• Primary Completion: 2026-09-15
• Study Completion: 2026-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic performance (benign or malignant)	At diagnosis time	Patient based bone lesion diagnostic performance (benign or malignant)

Secondary Outcome Measures

Name	Time	Method
Diagnostic performance (primary or metastases)	At diagnosis time	Patient based bone lesion diagnostic performance (primary or metastases)
Pathology prediction	At diagnosis time	Pathology prediction
Gene prediction	At diagnosis time	Gene prediction
Prognosis prediction	At diagnosis time	Prognosis prediction