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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01668238
Recruitment Status : Unknown
Verified August 2012 by XU Zhi, Peking University.
Recruitment status was:  Recruiting
First Posted : August 20, 2012
Last Update Posted : August 20, 2012
Peking University
Information provided by (Responsible Party):
XU Zhi, Peking University

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.

Condition or disease
Thyroid Tumor Breast Tumor

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.

Study Type : Observational
Estimated Enrollment : 600 participants
Time Perspective: Cross-Sectional
Official Title: Detection of Benign and Malignant Thyroid and Breast Tumors by Fourier Transform Infrared Spectrometry
Study Start Date : August 2011
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid
U.S. FDA Resources

malignant tumor
Inpatients with malignant tumors of thyroid and breast
benign tumor
Inpatients with benign tumors of thyroid and breast
Healthy volunteers
Volunteers without thyroid or breast tumors

Primary Outcome Measures :
  1. pathologic findings [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  1. Hospitalized patients undergoing thyroid and breast tumor sugery;
  2. Healthy volunteers


  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01668238

Contact: Zhi XU, PHD MD 86-10-82267331
Contact: Long Cui 86-10-82267328

China, Beijing
Peking University Third Hospital Recruiting
Beijing, Beijing, China, 100191
Contact: Zhi XU, PhD MD    86-10-82267331   
Contact: Long Cui    82267328   
Sponsors and Collaborators
XU Zhi
Peking University
Principal Investigator: Zhi Xu, PhD MD Peking University Third Hospital

Responsible Party: XU Zhi, Professor, Peking University Identifier: NCT01668238     History of Changes
Other Study ID Numbers: PUCRP201105
First Posted: August 20, 2012    Key Record Dates
Last Update Posted: August 20, 2012
Last Verified: August 2012

Keywords provided by XU Zhi, Peking University:
Thyroid tumor
Breast tumor
Fourier Transform Infrared Spectrometry
Tumor Diagnosis

Additional relevant MeSH terms:
Thyroid Diseases
Breast Neoplasms
Thyroid Neoplasms
Endocrine System Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Head and Neck Neoplasms