PET/CT Evaluation of Treatment Response in Breast Cancer
2017年6月26日 更新者：A Bapsi Chakravarthy, MD、Vanderbilt-Ingram Cancer Center
Positron Emission Tomography (PET)-Computed Tomography (CT) PET/CT Evaluation of Treatment Response in Breast Cancer
The purpose of this study is to develop Positron Emission Tomography (PET) - Computed Tomography (CT) PET/CT imaging methods for looking at the effects of chemotherapy in breast cancer.
研究概览
地位
终止
条件
研究类型
介入性
注册 (实际的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Tennessee
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Nashville、Tennessee、美国、37232
- Vanderbilt-Ingram Cancer Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria
- Subjects must have histologically proven breast cancer
- Subjects are being considered for preoperative chemotherapy
- Subjects must be ≥ 18 years old. Sensor Sub-Study Only
- Palpable subcutaneous or known disease with one surface <1cm below surface of skin.
- A subset of patients who have a mass located on any surface of the breast that is accessible for Lucerno sensor placement will have additional testing.
Exclusion Criteria
- Children will be excluded from this study.
- Pregnant women and women who are breast feeding will be excluded from this study. (The Vanderbilt University Medical Center radiology "PET Procedure Screening Form" will be used to identify and exclude subjects who are pregnant or breastfeeding. A urine pregnancy test/or serum beta HCG will also be performed for women of child bearing potential).
- Patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study.
- Intraluminal lesions will be excluded from the sensor sub-study.
- Non biopsy proven malignancy will be excluded from this study.
- Palpable subcutaneous or known disease with one surface >1cm below surface of skin will be excluded from the sensor sub-study.
- Draining or exposed malignant tumor will be excluded from the sensor sub-study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：fluorodeoxyglucose PET/CT (FDG-PET/CT)
A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy.
Each patient will have up to three scans in a 6 month time frame.
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Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV.
Time interval between administration and scanning: 60 +/- 10minutes post-injection.
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实验性的：fluorodeoxythymidine PET/CT (FLT-PET/CT)
A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy.
Each patient will have up to three scans in a 6 month time frame.
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Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The Difference in the Change (Pre and End-treatment) of Standard Uptake Value (SUV) Between Pathological Non-responders and Responders (pCR)
大体时间：up to 6 months (1 scan prior to chemotherapy and 2 scans prior to surgery)
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The quantitative measures of standard uptake value (SULpeak and SULmax, prone and supine position) from PET were obtained.
SUV = (Tracer activity in tissue)/(Injected radiotracer dose/patient weight or lean body mass) with unit microcuries/g/(millicuries/kg) (no unit after simplification).
The SUV was averaged over the tumor regions.
These averages were computed for each patient at each time point.
All patients were were planned to be scanned three times: prior to treatment, during treatment and at the end of treatment.
The change of SUV was calculated as the end of treatment value minus the pre-treatment value.
Then the difference in the change between the responders and non-responders were estimated using Wilcoxon rank sum test.
The pseudomedians and nonparametric confidence intervals for the difference (change of non-responders minus the change of responders) were reported for parameters SULpeak and SULmax measured for different positions.
Pathological response were measured at the
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up to 6 months (1 scan prior to chemotherapy and 2 scans prior to surgery)
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Compare and Combine Magnetic Resonance Imaging (MRIs) (Obtained From Study BRE0588) and Positron Emission Tomography/ Computed Tomography (PET/CT) Methods to Develop a Robust Assessment of Tumor Status.
大体时间：48 months
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48 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年10月1日
初级完成 (实际的)
2015年4月1日
研究完成 (实际的)
2015年4月1日
研究注册日期
首次提交
2010年9月29日
首先提交符合 QC 标准的
2010年10月14日
首次发布 (估计)
2010年10月18日
研究记录更新
最后更新发布 (实际的)
2017年7月2日
上次提交的符合 QC 标准的更新
2017年6月26日
最后验证
2017年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Radiopharmaceutical Administration [18F]-FDG的临床试验
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Affiliated Hospital of Jiangnan University招聘中
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Fifth Affiliated Hospital, Sun Yat-Sen University招聘中
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Peking University Cancer Hospital & Institute未知