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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Peking University
Sponsor:
Collaborator:
Peking University
Information provided by (Responsible Party):
XU Zhi, Peking University
ClinicalTrials.gov Identifier:
NCT01668238
First received: August 7, 2012
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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
Thyroid Tumor
Breast Tumor

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Detection of Benign and Malignant Thyroid and Breast Tumors by Fourier Transform Infrared Spectrometry

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • pathologic findings [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 600
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)
Groups/Cohorts
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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  1. Hospitalized patients undergoing thyroid and breast tumor sugery;
  2. Healthy volunteers
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668238

Contacts
Contact: Zhi XU, PHD MD 86-10-82267331 xuzhi123456@sohu.com
Contact: Long Cui 86-10-82267328 cuilong1978@163.com

Locations
China, Beijing
Peking University Third Hospital Recruiting
Beijing, Beijing, China, 100191
Contact: Zhi XU, PhD MD    86-10-82267331    xuzhi123456@sohu.com   
Contact: Long Cui    82267328    cuilong1978@163.com   
Sponsors and Collaborators
XU Zhi
Peking University
Investigators
Principal Investigator: Zhi Xu, PhD MD Peking University Third Hospital
  More Information

No publications provided

Responsible Party: XU Zhi, Professor, Peking University
ClinicalTrials.gov Identifier: NCT01668238     History of Changes
Other Study ID Numbers: PUCRP201105
Study First Received: August 7, 2012
Last Updated: August 14, 2012
Health Authority: China: Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 01, 2014