Clinical trial NCT01668238: Detection of Benign and Malignant Thyroid and Breast Tumors by Fourier Transform Infrared Spectrometry
Official title: Detection of Benign and Malignant Thyroid and Breast Tumors by Fourier Transform Infrared Spectrometry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Tumor
Breast Tumor
Keywords: Thyroid tumor
Breast tumor
Fourier Transform Infrared Spectrometry
Tumor Diagnosis
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Peking University
First posted: 2012-08-20
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Hospitalized patients undergoing thyroid and breast tumor sugery;
2. Healthy volunteers

Brief 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.

Eligibility 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.

Primary outcomes:
measure: pathologic findings
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Zhi Xu, PhD MD
role: PRINCIPAL_INVESTIGATOR
References: