PET-CT in the Initial Staging of Breast Cancer and in the Early Assessment of Response to Neoadjuvant Chemotherapy (ASAINT)
Role of Fluorodeoxyglucose (FDG) PET-CT in the Initial Staging of Breast Cancer (ASAINT 1) and in the Early Assessment of Response to Neoadjuvant Chemotherapy (ASAINT 2)
The two main objectives of this prospective study are:
- to identify those patients for whom pre-treatment FDG (Fluorodeoxyglucose) PET (positron emission tomography) CT-scan (Computed tomography scan) provides useful information for the treatment of breast cancer (ASAINT 1),
- to improve FDG PET-CT-scan imaging criteria for assessing response to neoadjuvant therapy early, in M0-patients (ASAINT 2).
The secondary objective is to better understand the interactions between the imaging parameters of FDG PET-CT-scan and biological and histological features of breast cancer .
This is a non-interventional study. Two PET-CT-scans are performed, one before starting treatment, and the other after 2 cycles of neoadjuvant chemotherapy. The two PET-CT-scans are prescribed by oncologists from the center of breast diseases Unit at St. Louis hospital, in Paris, France. Oncologists provide clear information to the patients on the purpose of the examination. The examinations are performed in the nuclear medicine department at St. Louis hospital. PET-CT-scans data, tumor characteristics, results of other imaging and biological tests, results of surgery and patient's follow-up are summarized in a "de-identified" file. This file has been declared to the National Commission on Informatics and Liberties (CNIL). The data in this file are established prospectively and secondary analyzed to assess the precise role of PET-CT-scans in the initial staging of breast cancer and to determine the optimal PET-CT-scans criteria to evaluate response to neoadjuvant treatment early.
研究概览
研究类型
注册 (预期的)
联系人和位置
学习地点
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Paris、法国、75010
- 招聘中
- Hopital Siant-louis
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接触:
- David Groheux, MD-PHD
- 电话号码:+33 630603009
- 邮箱:david.groheux@aphp.fr
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria :
- Histologically confirmed breast cancer
- Stage II and III breast cancer
- Neo-adjuvant chemotherapy
- Baseline PET-CT-scan (ASAINT 1 and 2)
- PET-CT-scans after second cycle of neo-adjuvant chemotherapy (ASAINT 2)
- Tumor biopsy for diagnosis and biological analysis with hormone receptors and Human Epidermal Growth Factor Receptor-2 (HER2) available
- Surgical intervention after completion of neo-adjuvant chemotherapy
- Evaluable pathological response
Exclusion Criteria :
- Other tumor localization
- Non controlled diabetes mellitus
- Pregnancy
学习计划
研究是如何设计的?
设计细节
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 |
---|---|---|
Pathological complete response in M0 patients at baseline PET (stage II-III)
大体时间:18 weeks
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Absence of residual cancer cells in the primary breast tumor and in axillary lymph nodes
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18 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Number of distant metastases (M1 patients at baseline PET)
大体时间:2 weeks
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Detection of distant metastases by FDG PET-CT
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2 weeks
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Number of metastatic nodes at baseline PET (axillary and extra-axillary)
大体时间:2 weeks
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Detection of metastatic axillary and extra-axillary nodes by FDG PET-CT
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2 weeks
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Standard uptake value on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
大体时间:2 weeks
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2 weeks
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Patients overall survival
大体时间:5 years
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5 years
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event free survival
大体时间:5 years
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5 years
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Patients overall survival
大体时间:3 years
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3 years
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event free survival
大体时间:3 years
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3 years
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Patients overall survival
大体时间:2 years
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2 years
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event free survival
大体时间:2 years
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2 years
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Total lesion glycolysis on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
大体时间:2 weeks
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2 weeks
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Metabolic tumor volume on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
大体时间:2 weeks
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2 weeks
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Tumor heterogeneity determined on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
大体时间:2 weeks
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2 weeks
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合作者和调查者
调查人员
- 首席研究员:David Groheux, MD-PhD、APHP, IUH, University Paris Diderot, Paris 7, SPC
- 学习椅:Matthieu Resche-Rigon, MD-PHD、DRCD APHP Paris
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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