First-in-human Imaging With 89Zr-DFO-pertuzumab in Patients With HER2 Positive Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-Related Adverse Events, including vital signs as Assessed by CTCAE v4.0
研究概览
简要总结
The purpose of this study is to test if an imaging agent called Zr-DFO-pertuzumab that finds HER2 proteins can be used to take pictures of HER2-positive cancer.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 years or greater
- •Any biopsy proven HER2-positive malignancy. ASCO guidelines will be used to define HER2-positivity for breast cancer. Similar guidelines will be used for other cancer types as appropriate.
- •At least one malignant lesion on CT, MR, or FDG PET/CT within 60 days of protocol enrollment
- •ECOG performance of 0-2
排除标准
- •Life expectancy < 3 months
- •Pregnancy or lactation
- •Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.
研究组 & 干预措施
Zr-DFO-pertuzumab (89Zr-DFO-pertuzumab) PET/CT
Zr-DFO-pertuzumab (89Zr-DFO-pertuzumab) PET/CT will be performed in patients with known HER2-positive malignancy. Patients with multifocal disease, as demonstrated on cross-sectional imaging studies, will be preferentially recruited.
干预措施: Zr-DFO-pertuzumab PET/CT (Drug)
结局指标
主要结局
Number of Participants With Treatment-Related Adverse Events, including vital signs as Assessed by CTCAE v4.0
时间窗: 1 year
Patients will be monitored closely for evidence of adverse events, including vital signs before and after tracer administration. The day after tracer administration, a physician will screen for any side effects requiring treatment. If a severe adverse effect (Common Terminology Criteria for Adverse Events grade 3 or 4) attributable to 89Zr-DFO-pertuzumab occurs in any patient, then further use of 89Zr-DFO-pertuzumab will be suspended and the protocol reviewed with the MSKCC Data Safety Monitoring Committee.
次要结局
未报告次要终点