Can 89Zr-atezolizumab PET Scan Identify Patients With Metastatic Invasive Lobular Breast Cancer Who Will Respond to Chemotherapy-immune Checkpoint Inhibition?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Change in tumor uptake between 89Zr-atezolizumab PET scan at baseline and after two carboplatin induction treatments, defined as decline or increase of standardized uptake value
研究概览
简要总结
The exploratory single center feasibility ImaGelato study is conducted as an imaging side study to the Dutch GELATO trial (Assessing efficacy of carboplatin and atezolizumab in metastatic lobular breast cancer). Ten patients with lobular metastatic breast cancer, who are included in the GELATO trial at the UMCG, are eligible for the ImaGelato study.
All patients will undergo two Zirconium-89 (89Zr)-atezolizumab positron emission tomography (PET) scans, one at baseline and one after two doses carboplatin induction treatment. The 89Zr-atezolizumab PET scan will be performed 4 days after tracer injection. Procedures within the ImaGelato study will be completed after the two 89Zr-atezolizumab PET scans, but patients will continue treatment with carboplatin combined with atezolizumab in the GELATO trial.
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
- •A patient must meet the inclusion criteria of the GELATO trial
- •Able to give written informed consent and to comply with the ImaGelato protocol
排除标准
- •Contra-indication for 89Zr-atezolizumab PET scan
- •Any approved anti-cancer therapy, including chemotherapy or hormonal therapy within ≤14 days prior to the first 89Zr-atezolizumab injection. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to the first 89Zr-atezolizumab injection.
结局指标
主要结局
Change in tumor uptake between 89Zr-atezolizumab PET scan at baseline and after two carboplatin induction treatments, defined as decline or increase of standardized uptake value
时间窗: 2 years
Change in tumor uptake between 89Zr-atezolizumab PET scan at baseline and after two carboplatin induction treatments, defined as decline or increase of standardized uptake value (SUV) of 30% or more, described as per lesion and per patient. For the two different time points we will calculate the SUV for all lesions and patients. Relative decrease or increase in SUV units between different time points will be calculated for all lesions and patients, and recorded as percentage of SUV decrease or increase.
次要结局
- The relation between standardized uptake value (SUV) on 89Zr-atezolizumab PET scan, to response to carboplatin-atezolizumab(2 years)
- The relation of 89Zr-atezolizumab tumor uptake at baseline and after two courses of carboplatin, with tumor biopsy assessments(2 years)
研究者
C.P. Schroder
principal investigator
University Medical Center Groningen