Detection of Benign and Malignant Thyroid and Breast Tumors by Fourier Transform Infrared Spectrometry
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- pathologic findings
研究概览
简要总结
The purpose of this stage of study is to establish discriminant among healthy tissue, benign and malignant thyroid and breast tumors by fourier transform infrared spectrometry variables.
详细描述
Recently,the methods to the diagnosis of tumors include palpation,X-ray,ultrasound,CT and MRI.The doctors could not get conclusion without a existing mass.The FNB is very popular nowadays in western countries,but it has been reported that about one-third malignant cases have been neglected by FNB,for the tissue isn't enough through the needle.There also have been reports about the increased auxilliary lymphnode metastases for breast cancer because of FNB.Although the Mammotome has been used widely,it is still traumatic.
Process of malignant transformation of tissues and cells, first proteins, lipids, carbohydrates and nucleic acids constitute the main substance of tissue and cell structure, conformation, and the number of occurrence of significant changes in subsequent histological changes. Fourier transform infrared spectroscopy is the major molecular bond coupling between the atoms vibrational spectra and molecular rotational spectra.
In this study, consists of three phases:
Stage one:
Continuous enrollment requires inpatient surgery 300 cases of thyroid cancer patients and breast cancer patients, 200 cases of preoperative determination of tumor on the surface infrared spectroscopy, infrared spectroscopy of the anterior tumor tissue and lymph node surgery, measured in vivo; at the same time into the group of 50 patients healthy people, the determination of surface infrared spectroscopy of the thyroid and breast area. Paraffin pathological findings as the gold standard, the thyroid and breast cancer patients were divided into the benign group and malignant group, relatively healthy and good, the distribution of differences of the surface infrared spectrum of malignant group, while relatively good in the malignant group IR spectra of the distribution of differences.
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing thyroid and breast tumor surgery.
- •Informed consent form is signed.
- •An optical fibre and ATR probe can be applied to the operation field in process of open or laparoscopic surgery.
- •Male or female between the age of 18 to
- •Patients can tolerate surgery and with non of these diseases: severe heart failure, liver failure, renal failure or respiratory failure.
排除标准
- •A state of emergency, such as Gastrointestinal bleeding, perforation, or acute obstruction.
- •unstable situation in operation, such as anesthetic accidents or intraoperative cerebral vascular accident.
- •From investigators' perspective patients do not suitable for the study
- •Healthy volunteers' inclusion criteria:
- •Informed consent form is signed.
- •No thyroid or breast cancer according to the professional judgment of general surgeon.
- •No thyroid or breast disease according to thyroid function tests and breast type B-ultrasonic test within 3 months.
结局指标
主要结局
pathologic findings
时间窗: 12 months
1. In operation patients, discriminant between benign and malignant thyroid and breast tumors are established by fourier transform infrared spectrometry variables, and pathologic diagnoses are gold standard. 2. Between Patients and healthy volunteers, discriminant are established among thyroid and breast tumors and healthy tissues.
次要结局
未报告次要终点
研究者
XU Zhi
Professor
Peking University