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NCT Number: NCT07196995

Validation of Whole Body PET/CT Foundation Model

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

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Key information

Conditions

Bone Metastases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diagnostic performance (benign or malignant)

    Time frame: At diagnosis time

    Patient based bone lesion diagnostic performance (benign or malignant)

Secondary outcomes

  1. Diagnostic performance (primary or metastases)

    Time frame: At diagnosis time

    Patient based bone lesion diagnostic performance (primary or metastases)

  2. Pathology prediction

    Time frame: At diagnosis time

    Pathology prediction

  3. Gene prediction

    Time frame: At diagnosis time

    Gene prediction

  4. Prognosis prediction

    Time frame: At diagnosis time

    Prognosis prediction

Sponsors and collaborators

Lead sponsor

Shanghai 6th People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 29, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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