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Validation of Whole Body PET/CT Foundation Model

Prospective Multicenter Validation of Whole Body PET/CT Foundation Model for Bone Lesion Detection

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07196995
Enrollment
180
Registered
2025-09-29
Start date
2025-10-16
Completion date
2026-12-15
Last updated
2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Metastases

Brief summary

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

Interventions

None listed

Sponsors

Shanghai 6th People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic performance (benign or malignant)At diagnosis timePatient based bone lesion diagnostic performance (benign or malignant)

Secondary

MeasureTime frameDescription
Diagnostic performance (primary or metastases)At diagnosis timePatient based bone lesion diagnostic performance (primary or metastases)
Pathology predictionAt diagnosis timePathology prediction
Gene predictionAt diagnosis timeGene prediction
Prognosis predictionAt diagnosis timePrognosis prediction

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026