NCT03295695撤回早期 1 期
Pilot Study of PET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient Before and After Neoadjuvant Chemotherapy
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Cardiac Ejection Fraction (EF)
研究概览
简要总结
This is a single arm, phase 0 study to evaluate the safety and efficacy of PET-CT scans with FDG-labeled RBC in patients with breast cancer.
Cardiac ejection fraction can be calculated and monitored in breast cancer patients during chemotherapy using a FDG-RBC PET-CT scan. The purpose of this study is to determine if calculated cardiac ejection fraction shows high concordance with results from echocardiography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have histologically confirmed breast cancer and be scheduled for neoadjuvant Trastuzumab- or anthracycline-based chemotherapy.
- •Age >18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky >60%).
- •Must be able to complete an informed consent process.
- •Must have normal organ and marrow function: leukocytes >3,000/μL; absolute neutrophil count >1,500/μL; platelets >100,000/μL; total bilirubin within normal institutional limits; aspartate aminotransferase (AST)[SGOT] / alanine aminotransferase (ALT)[SGPT]: less than 2.5 X institutional upper limit of normal; Creatinine within normal institutional limits - OR - creatinine clearance>60 mL/min/1.73 m^2 for patients with creatinine level above institutional normal.
- •Echocardiogram results should be of sufficiently suitable quality (adequate acoustic window access) to provide a reliable ejection fraction range calculation. The cardiac ejection fraction on the pre-treatment echocardiogram should be 50% or higher.
- •Participants should be naïve to Trastuzumab or anthracycline chemotherapy prior to enrollment.
排除标准
- •Prior history of invasive breast cancer and treatment with anthracycline chemotherapy.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to FDG.
- •Known symptomatic coagulopathies, bleeding diathesis, hemoglobinopathies, or hemolytic anemia.
- •Participants should have no clinically significant heart disease such as congestive heart failure. Participants should not have other significant structural heart disease by echocardiogram, or cardiac dysrhythmia on standard of care electrocardiogram that may adversely affect the cardiac imaging results obtained with FDG-RBC PET-CT imaging.
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Women who are pregnant.
- •Found to have a cardiac ejection fraction less than 50% on the pre-treatment echocardiogram.
结局指标
主要结局
Cardiac Ejection Fraction (EF)
时间窗: Up to 12 months
Calculated cardiac ejection fraction (EF) with a low radiation dose FDG-RBC PET-computed tomography (CT) scan before and after neoadjuvant chemotherapy.
次要结局
- Concordance Between FDG-RBC PET-CT and Echocardiogram(Pre-treatment and Post-treatment, up to 12 months)
研究者
研究点 (2)
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