Phase II Trial: uPAR PET/CT and FDG PET/MRI for Preoperative Staging of Bladder Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- uPAR PET/CT: regional lymph node metastases
研究概览
简要总结
The sensitivity and specificity of uPAR PET/CT with the radioligand 68GaNOTA-AE105 and FDG PET/MRI for preoperative detection of regional lymph node metastases in urinary bladder cancer
详细描述
The sensitivity and specificity of 68Ga-NOTA-AE105 PET/CT and FDG PET/MRI for detection of regional lymph node metastases will be tested by observer-blinded readings and compared to diagnostic performance of conventional preoperative procedure. The reference test will be histopathology of lymph nodes obtained by operative lymph node dissection based on 6 regions. The suspected lymph nodes will be assigned to 6 regions based on the images. During the following operation the lymph nodes will be removed and analysed in each of these regions.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-verified urinary bladder cancer
- •The participants must be capable of understanding and giving full informed written consent age above 18 years
排除标准
- •Pregnancy
- •Lactation/breast feeding
- •Age above 85 years old
- •Weight above 140 kg
- •Treatment with neoadjuvant chemotherapy
- •Known allergy towards 68Ga-NOTA-AE105
- •Other malignant disease within last 5 years, except for non-melanoma
研究组 & 干预措施
uPAR PET/CT and FDG PET/MR
One injection of 68Ga-NOTA-AE105 followed by PET/CT and on a separate day one injection of 18F-FDG followed by PET/MRI. Both scans will be evaluated for possible regional lymph node metastases.
干预措施: Injection of 68Ga-NOTA-AE105 (Drug)
uPAR PET/CT and FDG PET/MR
One injection of 68Ga-NOTA-AE105 followed by PET/CT and on a separate day one injection of 18F-FDG followed by PET/MRI. Both scans will be evaluated for possible regional lymph node metastases.
干预措施: Injection of 18F-FDG (Drug)
uPAR PET/CT and FDG PET/MR
One injection of 68Ga-NOTA-AE105 followed by PET/CT and on a separate day one injection of 18F-FDG followed by PET/MRI. Both scans will be evaluated for possible regional lymph node metastases.
干预措施: Positron Emission Tomography and CT (Device)
uPAR PET/CT and FDG PET/MR
One injection of 68Ga-NOTA-AE105 followed by PET/CT and on a separate day one injection of 18F-FDG followed by PET/MRI. Both scans will be evaluated for possible regional lymph node metastases.
干预措施: Positron Emission Tomography and MRI (Device)
结局指标
主要结局
uPAR PET/CT: regional lymph node metastases
时间窗: evaluated on uPAR-PET/CT scan performed within 1 hour following injection of 68Ga-NOTA-AE105
Sensitivity of uPAR-PET/CT detection of regional lymph node metastases by 68Ga-NOTA-AE105 PET/CT
FDG PET/MRI: regional lymph node metastases
时间窗: evaluated on FDG PET/MRI performed within 1 hour following injection of 18F-FDG
Sensitivity of FDG-PET/MRI for detection of regional lymph node metastases
次要结局
- uPAR PET/CT: Number of lymph node metastases(evaluated on uPAR-PET/CT performed within 1 hour following injection of 68Ga-NOTA-AE105)
- uPAR PET/CT: sensitivity for detection of distant metastases(evaluated on uPAR-PET/CT performed within 1 hour following injection of 68Ga-NOTA-AE105)
- FDG PET/MRI: sensitivity for detection of distant metastases(evaluated on uPAR-PET/CT performed within 1 hour following injection of 18F-FDG)
- FDG PET/MRI: Number of lymph node metastases(evaluated on FDG PET/MRI performed within 1 hour following injection of 18F-FDG)
研究者
Dorthe Skovgaard
MD, Phd
Rigshospitalet, Denmark