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临床试验/NCT06086327
NCT06086327招募中早期 1 期

Chemokine Receptor CXCR4-targeting PET Imaging for Thymoma

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年6月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
招募中
入组人数
100
试验地点
1
主要终点
SUVmax and SUVmean

研究概览

简要总结

Chemokine receptor CXCR4 was expressed in T cells and CXCR4-targeting molecular imaging- 68Ga-Pentixafor PET/CT could be a promising technique to evaluate the extent of thymoma with higher accuracy. This prospective study is going to investigate whether metabolic characterization by 68Ga-Pentixafor PET/CT may be superior for diagnosis, distinguish evaluation for thymoma.

详细描述

Thymoma is 1 rare type of tumor developed on the thymic epithelium; patients with thymoma also might have myasthenia gravis (MG). Because of the scarcity and complexity of MG-associated thymoma, its pathogenesis and etiology still remain unclear nowadays. The expression of C-X-C chemokine receptor type 4 (CXCR4) is absent or low in most healthy tissues but highly expressed in various types of tumors. CXCR4 might contribute to the clinical cancer progression, and CXCR4 could be a valuable prognostic biomarker in the therapy of MG-associated thymoma.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • suspected or confirmed untreated thymoma patients
  • signed written consent.

排除标准

  • pregnancy
  • breastfeeding
  • known allergy against Pentixafor
  • any medical condition that in the opinion of the investigator,may
  • significantly interfere with study compliance.

研究组 & 干预措施

68Ga-Pentixafor, PET/CT

Experimental

Inject 68Ga-Pentixafor and then perform PET/CT scan.

干预措施: 68Ga-Pentixafor (Drug)

结局指标

主要结局

SUVmax and SUVmean

时间窗: through study completion, an average of 1.5 years

SUVsof focal lesions are measured on 68Ga-Pentixafor PET/CT. The SUVs of the blood pool and muscle are defined as the background activity on the condition that there is no focally hypermetabolic disease.

次要结局

  • Diagnostic value(through study completion, an average of 1.5 years)
  • Diagnostic value in special type of thymoma(through study completion, an average of 1.5 years)
  • CXCR4 expression and SUV(through study completion, an average of 1.5 years)
  • Diagnostic value in thymoma and other masses(through study completion, an average of 1.5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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