NCT03331601终止2 期
Evaluation of 68GaNOTA-Anti-HER2 VHH1 Uptake in Brain Metastasis of Cancer Patients
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- The tumor targeting potential in brain metastasis
研究概览
简要总结
This study investigates the uptake of the radiopharmaceutical 68-GaNOTA-Anti-HER2 VHH1 in brain metastasis using PET/CT imaging. Patients with HER2-positive and HER2-negative cancer will be included and the uptake in their lesions will be compared.
Optional 68-GaNOTA-Anti-HER2 VHH1 scans may be performed during or after treatment, at time points 12±6 weeks and 24±9 weeks after the first scan.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have given informed consent
- •Age 18 years or older
- •Patients with brain metastasized cancer, with at least 1 brain lesion of at least 8 mm maximal diameter, as measured by CT or MRI.
- •Patients with potentially HER2-positive cancer. Either a HER2 staining should have been done in standard of care, or sufficient tissue should be available for HER2-staining for study purpose.
排除标准
- •Pregnant patients
- •Breast feeding patients
- •Patients with recent (< 1 week) gastrointestinal disorders with diarrhea as major symptom
- •Patients with any serious active infection
- •Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the test radiopharmaceutical
- •Patients who cannot communicate reliably with the investigator
- •Patients at increased risk of death from a pre-existing concurrent illness
结局指标
主要结局
The tumor targeting potential in brain metastasis
时间窗: 90 min post injection
The tumor targeting potential in brain metastasis will be visually scored as positive or negative by an experienced nuclear medicine physician, unaware of the HER2-status.
次要结局
- Change in uptake in brain lesions evaluated by PET/CT scan during or after treatment(up to 2 years after inclusion)
研究者
研究点 (2)
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