NCT01240681已完成不适用
A Pilot Study of Blood Oxygen Level Dependent Magnetic Resonance Imaging (BOLD MRI) and Fluorothymidine Positron Emission Tomography (FLT PET) in Patients With Locally Advanced Breast Cancer Undergoing Neoadjuvant Chemotherapy
Ontario Clinical Oncology Group (OCOG)7 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2011年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 7
- 主要终点
- Clinical response (partial and complete)
研究概览
简要总结
The objective of this pilot study is to determine the effectiveness of Fluorothymidine Positron Emission Tomography (FLT PET) and Blood Oxygen Level Dependent Magnetic Resonance Imaging (BOLD MRI) in assessing tumour response to neoadjuvant chemotherapy (NA CT) in women with locally advanced breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologic proof of breast cancer (invasive ductal or lobular carcinoma). Breast sarcoma and lymphoma are not eligible.
- •Clinical diagnosis of locally advanced breast cancer (Stage IIB (T3,N0,M0), Stage IIIA, IIIB, or IIIC, according to American Joint Committee on Cancer (AJCC) Tumour-Node-Metastasis (TNM) Cancer Staging), including inflammatory breast cancer.
- •Ability to undergo neoadjuvant chemotherapy.
排除标准
- •Evidence of metastatic disease (identified on chest x-ray, liver ultrasound, bone scan or other imaging tests);
- •Previous chemotherapy or hormonal therapy for breast cancer;
- •Significant concurrent medical problems that result in the patient being unfit for surgery (e.g. uncontrolled diabetes, active cardiac disease, severe chronic obstructive pulmonary disease);
- •Known pregnancy or lactating female (e.g. positive serum beta human chorionic gonadotropin (B-hCG) pregnancy test);
- •Inability to lie supine for imaging with Positron Emission Tomography (PET);
- •Any contraindication to undergoing Magnetic Resonance Imaging (MRI) or PET;
- •Currently receiving Antabuse;
- •Inability to provide informed consent (e.g. dementia or severe cognitive impairment).
结局指标
主要结局
Clinical response (partial and complete)
时间窗: 6 months (approximately)
Partial clinical response refers to at least a 50% reduction in the dimensions of the tumour mass and a complete clinical response refers to complete absence of the mass on physical exam, as well as absence of inflammation, ulceration and peau d'orange.
次要结局
- Pathologic response(6 months (approximately))
- Imaging Quantification(6 months (approximately))
研究者
研究点 (7)
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