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临床试验/NCT03969524
NCT03969524Unknown不适用

Superadded Value of Functional MRI Techniques in Evaluation of Malignant Breast Cancers Following Clips Guided Neoadjuvant Chemotherapeutic Series

Assiut University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年6月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
changes in the different functional technique's parameters according to the type of response.

研究概览

简要总结

• Address the accuracy of functional MRI techniques to predict response to neoadjuvant chemotherapy given to local advanced breast cancer patients with correlation with pathology thus allowing early chemotherapy regimen modification to increase number of patients achieving pathological complete response or save patients from toxic effects of ineffective chemotherapy.

详细描述

patient selection:

Selection of patients diagnosed with of biopsy proven breast cancer (BIRAD VI ) :

• Inclusion criteria: patient in different age groups with local advanced breast cancer who are eligible for neoadjuvant chemotherapy and breast conservative surgery and in need for clip placement for tumor localization

Breast cancer (BC) is the second most common cancer in the world and by far the most frequent cancer among women. In Egypt the incidence rate of breast cancer is 29.9/100,000 population in the age group of 30-34 years with the highest population among young women. (1).

Management of breast cancer depends upon its stage. Early stages (stage I) with small sized breast masses undergo breast conservative surgery (BCS) while locally advanced breast masses (stage II and III) may require Preoperative administration of Neoadjuvant chemotherapy (NAC) to decrease the tumor burden allowing for BCS instead of mastectomy with no significant difference in disease-free survival for patients receiving breast conservation in comparison to mastectomy.(2, 3)

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • patient in different age groups with local advanced breast cancer who are eligible for neoadjuvant chemotherapy and breast conservative surgery and in need for clip placement for tumor localization

排除标准

  • Patient with breast cancer who are not eligible for NAC (pregnant patients, multicentric breast cancer, metastatic breast cancer).
  • Patients who have received any prior chemotherapy, radiation therapy or tamoxifen therapy for their current breast cancer
  • Patients with any general contraindication to MRI as presence of any paramagnetic substance as pacemakers, or those with claustrophobia.

结局指标

主要结局

changes in the different functional technique's parameters according to the type of response.

时间窗: 3 years

by appropriate statistical test

correlations coefficient between functional techniques of MRI breast and histology

时间窗: 3 years

by appropriate statistical test

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heba Sabet

Assistant lecturer of Radiology

Assiut University

研究点 (1)

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