PET-MR Fusion Imaging and Surrogate Marker for Prediction and Monitoring of Response to Neoadjuvant Chemotherapy in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Patholocial Response to Chemotherapy
研究概览
简要总结
The purpose of this study is:
To validate the efficacy of multiparametric MRI, FDG-PET, RGD-PET, and PET-MR fusion imaging in the prediction and monitoring response to neoadjuvant chemotherapy of locally advanced breast cancer patients.
To identify the optimal combination parameters of MR spectroscopy, diffusion-weighted MRI, dynamic contrast-enhanced MRI, FDG-PET, and RGD-PET in the prediction and monitoring response to neoadjuvant chemotherapy of locally advanced breast cancer patients.
To compare the performances of dynamic contrast-enhanced MRI using parametric response map analysis versus those of pharmacokinetic parameters (Ktrans, kep, or Ve) in the early prediction of pathological responsiveness to neoadjuvant chemotherapy in breast cancer patients
详细描述
Enrolled women with breast cancers who had received an anthracycline-taxane regimen and subsequent surgery were prospectively enrolled. DCE-MRI and FDG-PET scan were performed before and after the 1st cycle of chemotherapy. MR imaging parameters and SUV on PET scan within a tumor were analyzed. Clinicopathologic (age, clinical tumor stage, hormonal receptor status, and surgery type) and imaging parameters were compared according to the pathological response.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed breast cancer
- •Clinical stage IIb, IIIa, IIIb, IIIc
- •Must have measurable disease
- •Performance status of ECOG 0-2
- •Adequate, bone marrow, liver, heart, and renal function
- •Who did not receive chemotherapy for breast cancer
- •Must agree with and signed informed consent
排除标准
- •Prior history of cancer besides breast cancer
- •Active bacterial infection
- •Pregnant or lactating women
- •Psychological disease or seizure
- •History of arrhythmia, congestive heart failure, myocardial infarct, or unstable angina
- •Male breast cancer
- •Who had a pacemaker or history of open heart surgery
结局指标
主要结局
Patholocial Response to Chemotherapy
时间窗: Post-operation
Pathological complete response (pCR) or non-pCR
次要结局
- Tumor Size(baseline, completion of 1st cycle of chemotherapy)
- Proportions of Voxels Within a Tumor With Increased or Decreased Signal Intensity (Parametric Response Map Signal Intensity; PRMSI)(Baseline, post-1st chemotherapy)
- Rate Constant of the Escape of the Contrast Agent From the Extracellular Extravascular Space Into the Plasma Compartment (Kep)(Baseline, post-1st chemotherapy)
- Extracellular Extravascular Space Per Unit Volume of Tissue (Ve)(Baseline, post-1st chemotherapy)
- Constant for the Transfer of the Contrast Agent From the Plasma Compartment Into the Extracellular Extravascular Space (Ktrans)(Baseline, post-1st chemotherapy)
- Total Choline Amount of the Tumor Measured on Single Voxel 1H-magnetic Resonance Spectroscopy(Baseline, post-1st chemotherapy)
- Tumor Volume(Baseline, post-1st chemotherapy)
- Standardized Uptake Value on 18F-fluoro-deoxy-glucose Positron Emission Tomography(Baseline, post-1st chemotherapy)
研究者
Woo Kyung Moon
Professor
Seoul National University Hospital