Evaluation of 68GaNOTA-Anti-HER2 VHH1 uptake in brain metastasis of cancer patients
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 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
研究概览
简要总结
To compare the uptake of 68GaNOTA-Anti-HER2 VHH1 in brain metastasis lesions from HER2-positive and HER2-negative patients
研究设计
- 研究类型
- Interventional
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 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 will be visually scored as positive or negative by an experienced nuclear medicine physician, unaware of the HER2-status
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
The tumor targeting potential in brain metastasis will be assessed quantitatively using Standard Uptake Values (SUV) by an experienced nuclear medicine physician, unaware of the HER2-status.
The tumor targeting potential in brain metastasis will be assessed quantitatively using Standard Uptake Values (SUV) by an experienced nuclear medicine physician, unaware of the HER2-status.
次要结局
- If available, uptake will be evaluated during and after treatment and compared to baseline values. Results will be compared to information of patient's disease course.
研究者
Prof. Dr. Tony Lahoutte
Scientific
Universitair Ziekenhuis Brussel