Quantitative Dynamic PET and MRI and Breast Cancer Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Number of Participants With Favorable Pathologic Response at Surgery
研究概览
简要总结
This clinical trial studies fludeoxyglucose F 18 (FDG) positron emission tomography (PET) and dynamic contrast-enhanced (DCE)-magnetic resonance imaging (MRI) in predicting response to treatment in patients with breast cancer. Comparing results of diagnostic procedures done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.
详细描述
PRIMARY OBJECTIVES:
I. To determine whether detailed kinetic analysis of FDG PET and magnetic resonance (MR) imaging studies for measures of tumor metabolism and blood perfusion can predict response and outcome for breast cancer patients undergoing neo-adjuvant therapy.
II. To compare the in vivo tumor biology associated with responsive and resistant tumors as measured by kinetic changes in FDG PET and MR imaging parameters to tumor subtypes analyzed from assay of pre-therapy biopsy and post-therapy surgical tissue.
OUTLINE:
Patients undergo FDG PET and DCE-MRI 1-2 weeks before prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).
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
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed breast cancer, determined to be a candidate for primary systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor following completion of neoadjuvant therapy
- •Primary tumor 2.0 cm or greater, and/or clinical evidence of axillary disease (palpable N1 or N2 or biopsy proven)
- •No obvious contraindications for primary chemotherapy
- •Able to lie still for PET and MRI scanning
- •Able to understand and willing to sign a written informed consent document and a Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
排除标准
- •Serious systemic illness other than breast cancer
- •Contraindication to MRI or history of adverse reaction to gadolinium
- •Evidence of distant disease outside of regional lymph nodes
- •Poorly controlled diabetes mellitus (fasting blood glucose > 200)
- •Prior systemic cancer therapy
结局指标
主要结局
Number of Participants With Favorable Pathologic Response at Surgery
时间窗: At time of surgery
The primary clinical endpoint is dichotomous (yes/no) - Has patient achieved favorable microscopic pathologic response at surgery? This favorable pathologic response is defined as: 1. No evidence of microscopic invasive tumor at the primary tumor site and in regional axillary lymph nodes = Residual Cancer Burden class 0 (RCB 0) 2. Minimal invasive residual disease at primary tumor site and/or in regional axillary lymph nodes = Residual Cancer Burden class I (RCB I)
次要结局
- Percent Change in PET K1 Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response(Baseline to up to 12 weeks (mid-therapy))
- Percent Change in Tumor Metabolism / Perfusion Ratio (MRFDG/K1) Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response(Baseline to up to 12 weeks (mid-therapy))
- Time From Surgery to Breast Cancer Recurrence(The time from surgery to breast cancer recurrence. If recurrence does not occur during follow-up, the endpoint will be censored at the time of last documented disease-free status.)
- Time of Surgery to Overall Survival(Overall survival from time of surgery. If death does not occur during follow-up, the endpoint will be censored at the date of last contact when the patient was verified as alive.)
- Percent Change in DCE-MRI Peak Percent Enhancement (Peak PE) Between Mid-therapy and Pre-therapy Breast MRI Scans and Its Association With Pathologic Response(Baseline to up to 12 weeks (mid-therapy))
研究者
Jennifer Specht
Principal Investigator
University of Washington