Detection of Benign and Malignant Thyroid and Breast Tumors by Fourier Transform Infrared Spectrometry
Recruitment status was: Recruiting
|Study Design:||Time Perspective: Cross-Sectional|
|Official Title:||Detection of Benign and Malignant Thyroid and Breast Tumors by Fourier Transform Infrared Spectrometry|
- pathologic findings [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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.
- Between Patients and healthy volunteers, discriminant are established among thyroid and breast tumors and healthy tissues.
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||September 2012|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Inpatients with malignant tumors of thyroid and breast
Inpatients with benign tumors of thyroid and breast
Volunteers without thyroid or breast tumors
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:
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.
Were enrolled, infrared spectroscopy and pathological specimens were collected at different stages. Paraffin pathological findings as the gold standard, were established two tumor surface, the infrared spectra of the fresh in vitro and in vivo for tumor benign or malignant diagnosis discrimination system.
Into the infrared spectra collected data on behalf of the above-mentioned discrimination system to verify its sensitivity, specificity and accuracy; both paraffin pathological findings as the gold standard to compare the infrared spectral discrimination systems and intraoperative frozen section pathology for the diagnosis of benign and malignant tumors correctly rate differences, to explore the clinical value of infrared spectroscopy discrimination system.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01668238
|Peking University Third Hospital|
|Beijing, Beijing, China, 100191|
|Principal Investigator:||Zhi Xu, PhD MD||Peking University Third Hospital|