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临床试验/NCT07196995
NCT07196995尚未招募不适用

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

Shanghai 6th People's Hospital0 个研究点目标入组 180 人开始时间: 2025年10月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
180
主要终点
Diagnostic performance (benign or malignant)

研究概览

简要总结

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Diagnostic performance (benign or malignant)

时间窗: At diagnosis time

Patient based bone lesion diagnostic performance (benign or malignant)

次要结局

  • Diagnostic performance (primary or metastases)(At diagnosis time)
  • Pathology prediction(At diagnosis time)
  • Gene prediction(At diagnosis time)
  • Prognosis prediction(At diagnosis time)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhao Hui

Principal Investigator

Shanghai 6th People's Hospital

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