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Detection of Benign and Malignant Thyroid and Breast Tumors by Fourier Transform Infrared Spectrometry

18 Years
80 Years
Open (Enrolling)
Thyroid Tumor, Breast Tumor

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Trial Information

Detection of Benign and Malignant Thyroid and Breast Tumors by Fourier Transform Infrared Spectrometry

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.



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

- 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

- No thyroid or breast disease according to thyroid function tests and breast type
B-ultrasonic test within 3 months.

Type of Study:


Study Design:

Time Perspective: Cross-Sectional

Outcome Measure:

pathologic findings

Outcome Description:

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.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Zhi Xu, PhD MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peking University Third Hospital


China: Ethics Committee

Study ID:




Start Date:

August 2011

Completion Date:

September 2012

Related Keywords:

  • Thyroid Tumor
  • Breast Tumor
  • Thyroid tumor
  • Breast tumor
  • Fourier Transform Infrared Spectrometry
  • Tumor Diagnosis
  • Breast Neoplasms
  • Thyroid Neoplasms
  • Thyroid Diseases