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临床试验/NCT05604482
NCT05604482已完成不适用

Detection of Disease Activity in Giant Cell Arteritis Using CXCR4-PET/CT

Matthias Fröhlich2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
2
主要终点
Maximum measurable tracer activity on 68Ga-Pentixafor PET/CT in the area of blood vessels in active GCA

研究概览

简要总结

Giant cell arteritis (GCA) is the most common vasculitis in the elderly. Accurate diagnosis is of utmost importance in order to then initiate the necessary immunosuppressive therapy. For large-vessel GCA (LV-GCA) involving the aorta and its branches, FDG-PET/CT is the standard in imaging for diagnosis and is recommended by the guidelines. However, this only indirectly visualizes inflammation through vessel wall uptake of glucose. A new PET tracer, 68Ga-pentixafor, is used to visualize the chemokine receptor CXCR4. This receptor is expressed by cells of the immune system. In the context of inflammatory processes, upregulation of CXCL12, the ligand of CXCR4, occurs in affected tissues. The chemotactic effect of this ligand leads to the immigration of CXCR4-positive inflammatory cells into the inflamed area, which can be visualized by PET using the CXCR4-specific tracer 68Ga-Pentixafor. The value of CXCR4-PET should therefore be tested in the context of LV-GCA. This study tests the benefit of CXCR4 in therapy-naïve patients with suspected LV-GCA. For this purpose, patients will receive a FDG-PET and a CXCR4-PET for direct comparison. This is an imaging-only study. Therapy will not be affected by the study. The study is single-arm and not blinded.

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

  • New diagnosis of GCA within 5 days of diagnosis or initiation or intensification of therapy.
  • Evidence of inflammatory activity based on clinical parameters, elevated serologic markers of inflammation (CRP > 1.0 mg/dl), or a positive imaging finding on vasculitis MRI, CCDS, or FDG-PET/CT
  • Ability of the patient to provide information
  • Exclusion of contraindications for the performance of a PET/CT examination (see below)

排除标准

  • Contraindications for the performance of a PET CT examination
  • Pregnancy
  • Allergies
  • Lack of capacity of the patient to give informed consent

结局指标

主要结局

Maximum measurable tracer activity on 68Ga-Pentixafor PET/CT in the area of blood vessels in active GCA

时间窗: 2 years

detection of maximum measurable tracer activity on 68Ga-Pentixafor PET/CT in the area of blood vessels after a maximum of 5 days after diagnosis or when acute inflammatory activity of GCA is detected in terms of recurrence.

次要结局

  • Correlation with clinical parameters(2 years)
  • Correlation with blood leukocyte count(2 years)
  • Comparison to other imaging modalities(2 years)

研究者

发起方
Matthias Fröhlich
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Matthias Fröhlich

Dr. med. Matthias Fröhlich

Wuerzburg University Hospital

研究点 (2)

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