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临床试验/NCT02599974
NCT02599974Unknown不适用

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)

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2006年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
1
主要终点
Pathological complete response in M0 patients at baseline PET (stage II-III)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Pathological complete response in M0 patients at baseline PET (stage II-III)

时间窗: 18 weeks

Absence of residual cancer cells in the primary breast tumor and in axillary lymph nodes

次要结局

  • event free survival(2 years)
  • Total lesion glycolysis on the FDG-PET (Fluorodeoxyglucose positron emission tomography)(2 weeks)
  • Metabolic tumor volume on the FDG-PET (Fluorodeoxyglucose positron emission tomography)(2 weeks)
  • Standard uptake value on the FDG-PET (Fluorodeoxyglucose positron emission tomography)(2 weeks)
  • Number of distant metastases (M1 patients at baseline PET)(2 weeks)
  • Number of metastatic nodes at baseline PET (axillary and extra-axillary)(2 weeks)
  • Patients overall survival(2 years)
  • Tumor heterogeneity determined on the FDG-PET (Fluorodeoxyglucose positron emission tomography)(2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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