跳至主要内容
临床试验/NCT07114211
NCT07114211尚未招募不适用

A Real-world Observational Study on the Diagnostic Value of 99mTc-FAPI Quantitative SPECT/CT Imaging in Adult Solitary Bone Lesions

Xijing Hospital0 个研究点目标入组 50 人开始时间: 2025年8月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
主要终点
SUVmax

研究概览

简要总结

Using the novel FAPI probe 99mTc-HYNIC-FAPI-04 and quantitative SPECT/CT imaging technology, this study investigates the diagnostic efficacy of 99mTc-HYNIC-FAPI-04 quantitative SPECT/CT in patients with common solitary bone lesions in adults, and compares its diagnostic performance with conventional CT, MRI, and 99mTc-MDP bone scintigraphy. Follow-up pathological results of patients post-surgery were analysed to assess the accuracy of 99mTc-HYNIC-FAPI-04 diagnostic outcomes, and its diagnostic value and significance were evaluated.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Benign solitary bone lesions in adults (fibrous cortical defects, fibrous hyperplasia, non-ossifying fibroma, osteoblastoma, osteoid osteoma, osteochondroma, etc.); Malignant solitary bone lesions in adults (osteosarcoma, Ewing's sarcoma, chondrosarcoma, malignant giant cell tumour of bone, etc.); Other fibroblast-rich bone lesions (chordoma, alveolar soft part sarcoma, fibrosarcoma, malignant fibrous histiocytoma, etc.).

排除标准

  • Severe liver and kidney dysfunction; Pregnant women and breastfeeding patients; Patients in poor physical condition who cannot tolerate the examination; Patients who cannot cooperate to complete the examination; Patients under the age of 18.

结局指标

主要结局

SUVmax

时间窗: 1 day from injection of the tracer

Maximum standardised intake value

SUVmean

时间窗: 1 day from injection of the tracer

Average standardised intake value

次要结局

未报告次要终点

研究者

发起方
Xijing Hospital
申办方类型
Other
责任方
Sponsor

相似试验