2024-511977-31-01招募中2 期
68Ga-FAPI-46 PET for Giant Cell Arteritis-Polymyalgia Rheumatica Spectrum Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The diagnostic accuracy of 68Ga-FAPI-46 PET/CT in patients with suspected GPSD.
研究概览
简要总结
To assess the diagnostic accuracy of 68Ga-FAPI-46 PET/CT in patients with suspected GPSD.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with suspected GPSD. In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Age ≥ 50 years - Patients must be able to adhere to the study appointments and other protocol requirements. - Patients must be capable of giving informed consent
排除标准
- •Patients with suspected GPSD. A potential subject who meets any of the following criteria will be excluded from participation in this study: - Suspected GPSD, - Presence of symptoms, imaging test result or biopsy findings suggesting cranial artery involvement in GPSD (‘cranial giant cell arteritis’) - Use of oral glucocorticoid treatment or disease modifying anti-rheumatic drugs at time of inclusion - Females with child bearing potential. Post-menopausal women with >12 months of amenorrhoea are considered to have no child bearing potential. Given the age distribution of patients with GPSD, exclusion of females with child bearing potential will not lead to recruitment bias in the study. - Research-related radiation exposure (cumulative ≥5 mSv) in the year before inclusion.
研究组 & 干预措施
[68Ga]FAPI-46
Test
干预措施: [68Ga]FAPI-46 (Drug)
结局指标
主要结局
The diagnostic accuracy of 68Ga-FAPI-46 PET/CT in patients with suspected GPSD.
The diagnostic accuracy of 68Ga-FAPI-46 PET/CT in patients with suspected GPSD.
次要结局
- 68Ga-FAPI-46 uptake after 28 days of standard treatment in patients with GPSD.
- 68Ga-FAPI-46 uptake after 6 months of standard treatment in patients with GPSD
研究者
K.S.M. van der Geest
Scientific
Universitair Medisch Centrum Groningen
研究点 (1)
Loading locations...
相似试验
招募中
2 期
The use of [68Ga]Ga-FAPI PET/MRI in assessing disease activity in patients with Graves’ orbitopathy2025-521163-12-01Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)10
招募中
2 期
[68Ga]Ga-FAPI total body PET/CT for improving diagnostic sensitivity and preoperative staging in gastroesophageal cancer and pancreatic cancer2023-503632-41-01Rigshospitalet
撤回
2 期
[68Ga]Ga-FAPI total body PET/CT for improving diagnostic sensitivity and preoperative staging in gastroesophageal cancer and pancreatic cancer2023-503632-41-00Rigshospitalet60
招募中
1 期
Application of [68Ga]Ga-NI-FAPI-04 PET/CT Imaging in Fibroblast Activation Protein Related DiseasesPulmonary FibrosisTumorNCT07464132Peking Union Medical College Hospital30
尚未招募
2 期
FAP PET/CT for Staging Patients With Breast CancerBreast Cancer DetectionNCT07523607Odense University Hospital65