NCT05982626招募中不适用
Study of 68Ga /131I SGMIB-ZT-199 PET Imaging Targeting HER2-positive in the Diagnosis of Metastatic Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Dosimetry
研究概览
简要总结
To evaluate the safety, biodistribution, radiation dosimetry, and uptake in tumor lesions of patients with Her2-positive metastatic breast cancer after injection of [131I]/[68Ga]SGMIB-ZT-199.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer patients.
- •Women aged between 18 and 75 years old.
- •Patients with breast cancer confirmed by histological examination or imaging.
- •HER2 positive diagnosis confirmed by puncture by immunohistochemistry or fluorescence in situ hybridization (HER2 positive is defined as immunohistochemistry result of 3+ (IHC 3+); or immunohistochemistry result of 2+/positive in situ hybridization result (IHC 2+/ISH+)).
- •Renal function: serum creatinine less than or equal to the upper limit of the normal range; electrocardiogram: no significant abnormalities.
- •Patients of childbearing age can cooperate with contraception.
- •Willing and able to cooperate with all items of this study.
排除标准
- •Subjects meeting any of the following criteria will be excluded from the study:
- •Severe hepatic or renal insufficiency;
- •Participation in another study protocol or clinical care within the past year that has resulted in radiation exposure exceeding an effective dose of 50 mSv in addition to the radiation exposure expected from participation in this clinical study.
- •Participation in this study is considered unsuitable by other investigators.
- •Pregnant women and other groups unsuitable to receive radiation.
- •Alcohol allergy, etc.
结局指标
主要结局
Dosimetry
时间窗: about 24hours from time of injection
To confirm biodistribution and absorbed doses of whole body, tumor lesions, and organs from \[131I\]SGMIB-ZT-199, assessed by PET/SPECT imaging.
次要结局
- Safety Assessment(From administration of [131I]SGMIB-ZT-199 until 1 week after injection)
研究者
研究点 (1)
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