A Phase II Study of Fluorodeoxyglucose (FluGlucoScan) in Patients With Breast Cancer: Correlation With Histologic Findings of Sentinel Node Biopsies and Axillary Dissection
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 199
- 试验地点
- 2
- 主要终点
- to determine whether preoperative PET imaging combined with sentinel node biopsy can accurately identify axillary node status
研究概览
简要总结
Breast cancer affects many women. One of the places to which it can spread is the lymph glands under the arm. The type of treatment offered to patients often will depend on whether those lymph glands have cancer in them or not. For this reason, a standard recommendation is that women with breast cancer have these lymph glands removed with surgery. This cancer causes side effects including numbness, pain, decreased ability to move the arm and arm swelling. A new type of surgery which looks only at the first gland that a cancer drains to (sentinel node biopsy) may help to avoid having to remove the glands under the arm. Also, a new way of imaging the glands under the arm called Positron Emission Tomography (PET) scanning may also give a better idea of the chance that these glands have cancer in them. This study is determining whether PET scans before surgery and sentinel node biopsy can decrease the need for a complete axillary dissection.
详细描述
1.0 Introduction
Breast cancer is the most common cancer in North American women. It is estimated that one in 8 American women will develop breast cancer during her lifetime. Surgical treatment has evolved from radical mastectomy to breast conservation, and systemic treatment has become increasingly important. The presence or absence of lymph node metastases is the most important prognostic factor used to determine type of systemic treatment necessary. Axillary dissection however, carries with it the risk of nerve injury, lymphedema, decreased arm motion and seroma formation. Clinical examination, ultrasound, CT scanning and MRI of the axilla are not sensitive or specific enough to eliminate the need for axillary dissection. Sentinel node biopsy (SNB) can predict the pathologic status of the axilla and theoretically could differentiate patients into those with positive node biopsies who require full dissection versus those who are negative and do not. Frozen section of the sentinel node is inaccurate and therefore SNB positive patients would require two surgical procedures. Positron Emission Tomography (PET) scanning of the axilla has been reported to have a high sensitivity and specificity and if used prior to surgery may guide the surgeon in determining the need for full axillary dissection versus SNB alone. PET scanning has also been reported to identify unsuspected distant metastases not found on standard staging examinations. This study will investigate the use of PET scanning in conjunction with SNB and results of both modalities will be correlated with histologic results of axillary dissection.
2.0 Objectives
There are no reports describing results of a similar study. By performing a properly constructed clinical trial in T1 - 3 N0 breast cancer patients, the question of whether PET scanning will make a difference to patient management can be answered. The hypothesis of this study is therefore, that a PET scan prior to surgery will facilitate staging both locally (axilla) and distant and will help the surgeon determine whether to do SNB or axillary dissection.
2.1 Primary Objective: To determine whether preoperative PET imaging combined with sentinel node biopsy can accurately identify nodal status. This would be most important in patients with a negative PET scan and negative sentinel nodes. If the combination of these tests was found to have a high negative predictive value for nodal metastases, full axillary dissection could be avoided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female. If female of child bearing potential and outside of the window of 10 days since the last menstrual period, a negative pregnancy test.
- •Biopsy proven breast carcinoma (core biopsy or fine needle aspiration, although core biopsies are preferred.)
- •Tumour size T1-3, N0 clinically
- •All patients will have pre-operative mammography +/- ultrasound of the breast
- •Age equal to or greater than 18 years
- •Able and willing to follow instructions and comply with the protocol
- •Provide written informed consent prior to participation in this study
排除标准
- •Nursing or pregnant females
- •Previous malignancy or diagnosis less than 10 (ten) years ago. Skin cancers (excluding malignant melanoma) and carcinoma in situ of the cervix are exceptions.
- •Excisional biopsy of the tumour has been performed
- •Age less than 18 years
- •Patient has diabetes
结局指标
主要结局
to determine whether preoperative PET imaging combined with sentinel node biopsy can accurately identify axillary node status
to assess the size limitations of PET scanning in metastatic lymph nodes
次要结局
- to determine the incidence of unsuspected distant metastases in patients with breast cancer
- to determine the value of a delayed scan time of approximately three hours after the injection of 18F-FDG