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Trial Title:
Detection of Benign and Malignant Thyroid and Breast Tumors by Fourier Transform Infrared Spectrometry
NCT ID:
NCT01668238
Condition:
Thyroid Tumor
Breast Tumor
Conditions: Official terms:
Neoplasms
Breast Neoplasms
Thyroid Neoplasms
Thyroid Diseases
Conditions: Keywords:
Thyroid tumor
Breast tumor
Fourier Transform Infrared Spectrometry
Tumor Diagnosis
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Cross-Sectional
Summary:
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.
Detailed description:
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.
Phase II:
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.
Phase III:
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.
Criteria for eligibility:
Study pop:
1. Hospitalized patients undergoing thyroid and breast tumor sugery;
2. Healthy volunteers
Sampling method:
Non-Probability Sample
Criteria:
Patients:
1. Inclusion Criteria:
- 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 80.
- Patients can tolerate surgery and with non of these diseases: severe heart
failure, liver failure, renal failure or respiratory failure.
2. Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Zip:
100191
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhi XU, PhD MD
Phone:
86-10-82267331
Email:
xuzhi123456@sohu.com
Contact backup:
Last name:
Long Cui
Phone:
82267328
Email:
cuilong1978@163.com
Start date:
August 2011
Completion date:
September 2012
Lead sponsor:
Agency:
XU Zhi
Agency class:
Other
Collaborator:
Agency:
Peking University
Agency class:
Other
Source:
Peking University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01668238