PET Imaging With 89Zr-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Investigate the use of [89Zr]-Df-Trastuzumab as a HER2 imaging agent
研究概览
简要总结
Our goal is to investigate the use of 89Zr-trastuzumab as a HER2 imaging agent to determine which patients are likely to respond to targeted HER2 agents as single agent therapy. We are proposing to perform a pilot study with goals of demonstrating the feasibility of imaging breast cancer patients with 89Zr-trastuzumab-PET/MRI, evaluating the relationship between tumor 89Zr-trastuzumab uptake and in vitro positivity of HER2, assessing the relationship between 89Zr-trastuzumab uptake and response to HER2 therapy.
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
- •Be at least 18 years of age.
- •Diagnosis of HER2 positive breast cancer as defined by to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2018 guidelines: Immunohistochemistry (IHC) 3+ OR Single prove In situ hybridization (ISH) with average HER2 copy number >= 6 OR dual probe ISH with both average HER2 copy number >= 4 AND HER2 to CEP17 ratio >=2
- •Patients eligible for radiation therapy or systemic therapy using a regimen containing at least one anti-HER2 agent
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 and 1
- •Ejection fraction greater than 50% by echocardiogram or multiple-gated acquisition (MUGA) scans
排除标准
- •Inability to provide informed consent
- •Pregnancy
- •Inability to lie still for the imaging study
- •Weight over 350 lbs., due to the scanner bore size
- •Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)
研究组 & 干预措施
[89Zr]-Df-Trastuzumab
[89Zr]-Df-Trastuzumab [89Zr]-Df-Trastuzumab will be administered intravenously. The administered dose will be 2 millicurie (mCi) at the time of injection. The amount of injected drug is 5 mg of Trastuzumab. 5-6 days post injection the patients will undergo PET/MRI imaging.
干预措施: [89Zr]-Df-Trastuzumab (Drug)
[89Zr]-Df-Trastuzumab
[89Zr]-Df-Trastuzumab [89Zr]-Df-Trastuzumab will be administered intravenously. The administered dose will be 2 millicurie (mCi) at the time of injection. The amount of injected drug is 5 mg of Trastuzumab. 5-6 days post injection the patients will undergo PET/MRI imaging.
干预措施: PET/MRI Imaging (Diagnostic Test)
结局指标
主要结局
Investigate the use of [89Zr]-Df-Trastuzumab as a HER2 imaging agent
时间窗: 24 months
To measure the diagnostic quality (with standardized uptake values) of PET/MRI imaging with \[89Zr\]-Df-Trastuzumab in patients with newly diagnosed breast cancer.
次要结局
未报告次要终点
研究者
Suzanne E. Lapi, PhD
Associate Professor of Radiology and Director, Cyclotron Facility
University of Alabama at Birmingham