64 Cu-DOTA-Trastuzumab Positron Emission Tomography in Women With Advanced HER2 Positive Invasive Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Tumor Uptake of 64Cu-DOTA-trastuzumab After 24 Hours
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as copper Cu 64-DOTA-trastuzumab-labeled PET, may help doctors to plan a better treatment
PURPOSE: This pilot trial is studying copper Cu 64-tetra-azacyclododecanetetra-acetic acid (DOTA)-trastuzumab-labeled positron emission tomography (PET) in women with human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
详细描述
PRIMARY OBJECTIVES:
I. Determine the dose of pre-administered cold antibody that optimizes image quality of 64Cu-DOTA-trastuzumab PET without increasing the radiation dose to the heart in women with metastatic HER2 positive breast cancer.
II. Determine whether tumor uptake on 64Cu-DOTA-trastuzumab PET correlates with tumor expression of HER2 in women with metastatic disease.
III. Perform an exploratory analysis of the relationship between uptake on 64Cu-DOTA-trastuzumab PET, HER2 overexpression, and inactivation of the PI3K/Akt pathway.
OUTLINE:
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eligibility Part I (Determination of the cold dose)
- •Participants must be women who have histological confirmation of metastatic invasive breast cancer that has metastasized outside the region of the primary tumor and axilla. Biopsy must be obtained within 28 days prior to study. Patients must have metastatic disease in lung, liver, soft-tissue or bone to qualify for the study (more than one site is permissible).
- •At least 1 non-hepatic site of metastasis greater than or equal to 2 cm in mean diameter must be identified in addition to the site that was biopsied.
- •The cancer must over express HER2 as determined by IHC and FISH.
- •Patients may have received trastuzumab in the adjuvant, neoadjuvant, or metastatic setting, but cannot have received the drug within the prior 2 months.
- •Participants must have normal cardiac ejection fraction.
- •Eligibility Part 2 (correlation of HER2 expression with PET uptake)
- •Participants must be women who have histological confirmation of metastatic invasive breast cancer that has metastasized outside the region of the primary tumor and axilla. Biopsy must be obtained within 28 days prior to study. Patients must have metastatic disease in lung, liver, soft-tissue or bone to qualify for the study (more than one site is permissible).
- •At least 1 non-hepatic site of metastasis site greater than or equal to 2 cm in mean diameter must be identified in addition to the site that was biopsied.
- •Participants with HER2 1+, 2+ and 3+ by IHC are eligible.
- •Patients may have received trastuzumab in the adjuvant, neoadjuvant, or metastatic setting, but cannot have received the drug within the prior 2 months.
- •Participants must have normal cardiac ejection fraction.
- •Ineligibility
- •Participants who have received trastuzumab within the prior 2 months
- •Participants who are not considered candidates for trastuzumab
- •Metastatic disease in a single site
- •No metastatic site greater than or equal to 2 cm
- •Concurrent malignancy other than skin cancer
- •Inability to provide informed consent
- •Participants who are pregnant
排除标准
- 未提供
结局指标
主要结局
Tumor Uptake of 64Cu-DOTA-trastuzumab After 24 Hours
时间窗: 24 hours after injection of 64 CU-DOTA-trastuzumab
Comparison of uptake between the HER2+ and HER2- groups, treating SUVmax measurements for individual tumors as independent observations. Statistical significance of differences in SUVmax between patient groups was assessed via a nonparametric (Wilcoxon rank-sum) test. Radiolabel uptake for tumors was measured in terms of single-voxel maximum SUV (SUVmax; SUV = tissue activity per mL x body weight \[g\]/injected activity decay-corrected to time of scan).
Tumor Uptake of 64Cu-DOTA-trastuzumab After 48 Hours
时间窗: 48 hours after injection of 64 CU-DOTA-trastuzumab
Comparison of uptake between the HER2+ and HER2- groups, treating SUVmax measurements for individual tumors as independent observations. Statistical significance of differences in SUVmax between patient groups was assessed via a nonparametric (Wilcoxon rank-sum) test. Radiolabel uptake for tumors was measured in terms of single-voxel maximum SUV (SUVmax; SUV = tissue activity per mL x body weight \[g\]/injected activity decay-corrected to time of scan).
次要结局
未报告次要终点