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IRCT20190904044697N7 IRCT 2021-02-16 Iran Nano Fund Thyroid Electrical Impedance Spectroscopy Clinical trial of Electrical Impedance Spectroscopy of Thyroid nodules for real-time discrimination of benign, atypical, and malignant lesions in patients candidate for surgery or biopsy 2021-02-19 anticipated 384 Complete https://irct.ir/trial/53998 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Diagnostic. N/A Condition 1: Malignant neoplasm of Thyroid. Condition 2: Benign tumor with solid mass. Condition 3: Secondary and unspecified malignant neoplasm of lymph nodes of head, face and neck. Intervention 1: Intervention group 1: Our surgical colleagues select some patients with solid tumors that are candidates for surgery and applying ETS based on inclusion criteria. After anesthetizing the patient, opening the skin around the neck, and giving access to the thyroid, the surgeon inserts the sterilized probe into the areas that he or she thinks are the most suspicious region. Then, by applying the electrical voltage, measurements are made in those areas according to the physician's discretion, and the raw spectroscopy information and classification parameters are stored and recorded, and the probe is removed without any sampling. Then, sampling is done from the same place to send to the pathology. Preliminary results of the sample pathology are received and re-diagnosed as blind by another pathologist. Intervention 2: Intervention group 2: Our radiological colleagues select some patients with solid tumors that are candidates of CNB or FNA for applying ETS based on inclusion and exclusion criteria. After anesthetizing the patient's skin, the radiologist inserts the sterilized probe into the areas that he or she thinks are the most suspicious regions. Then, by applying an electrical voltage, measurements are made in those areas according to the physician's discretion, and the raw spectroscopy information and classification parameters are stored and recorded, and the probe is removed without any sampling. Then, FNA or CNB is done from the same place to send to the pathology. Preliminary results of the sample pathology are received and re-diagnosed as blind by another pathologist. Yes - There is a plan to make this available What will be shared: 60% of the information about the primary outcome after de-identifying the participants, can be shared. When: Starting six months after publication. To whom: The data will be available for medical staff and academic institutions Conditions: Non-identifiable personal data will not be usable for the applicant and will only inform the patient of a positive clinical trial that the device is functioning properly. Where to obtain: Applicants can request data access via email. The data will be available to the applicant in a categorized manner with pathology reports. How to obtain: We will send the data to the applicant in one week. Comments:
public Dr. Mohammad Abdolahad
Nano bio electronic lab, ground floor, school of electrical and computer engineering, university of Tehran faculty of engineering, North Kargar Ave.
Tehran Iran (Islamic Republic of) 1439957131 +98 21 8802 8367 m.abdolahad@ut.ac.ir Tehran University of Medical Sciences scientific Mohammad Abdolahad
North Kargar Ave
Tehran Iran (Islamic Republic of) 14395/515 +98 21 8802 8367 m.abdolahad@ut.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Patients candidate for Thyroid surgery Patients candidate for Parathyroid surgery Patients candidate for dissection of neck lymph nodes Patients candidate for Thyroid biopsy Patients candidate for neck lymph nodes biopsy no limit no limit Both No exclusion criteria for patients candidate for Thyroid surgery High blood pressure patients (for ETS tests before biopsy) Patients taking anticoagulants (for ETS tests before biopsy) C73 D34 C77.0 Malignant neoplasm of Thyroid Benign neoplasm of thyroid gland Secondary and unspecified malignant neoplasm of lymph nodes of head, face and neck Diagnosis Diagnosis Intervention group 1: Our surgical colleagues select some patients with solid tumors that are candidates for surgery and applying ETS based on inclusion criteria. After anesthetizing the patient, opening the skin around the neck, and giving access to the thyroid, the surgeon inserts the sterilized probe into the areas that he or she thinks are the most suspicious region. Then, by applying the electrical voltage, measurements are made in those areas according to the physician's discretion, and the raw spectroscopy information and classification parameters are stored and recorded, and the probe is removed without any sampling. Then, sampling is done from the same place to send to the pathology. Preliminary results of the sample pathology are received and re-diagnosed as blind by another pathologist. Intervention group 2: Our radiological colleagues select some patients with solid tumors that are candidates of CNB or FNA for applying ETS based on inclusion and exclusion criteria. After anesthetizing the patient's skin, the radiologist inserts the sterilized probe into the areas that he or she thinks are the most suspicious regions. Then, by applying an electrical voltage, measurements are made in those areas according to the physician's discretion, and the raw spectroscopy information and classification parameters are stored and recorded, and the probe is removed without any sampling. Then, FNA or CNB is done from the same place to send to the pathology. Preliminary results of the sample pathology are received and re-diagnosed as blind by another pathologist. The pathologic classification of thyroid nodules or metastatic neck lymph nodes. Timepoint: before dissection of the thyroid nodule, suspicious lymph node or parathyroid nodule for patients candidate for surgery / before FNA or CNB from thyroid nodule or suspicious lymph nodes for patients candidate for biopsy. Method of measurement: Electrical Impedance Spectroscopy (impedance phase slope in frequency ranges of 100kHz to 500 kHz). Investigation of ETS in decreasing unrequired biopsy or surgery of benign thyroid lesions. Timepoint: after finishing the trial. Method of measurement: By comparing FNA pathology results and impedance spectroscopy results of patients candidate for thyroid surgery. Iran Nano Fund Approved 2018-08-18 Ethics committee of Tehran University of Medical Sciences No.23, 16 Azar Ave, Enghelab Ave,Tehran,Iran Tehran Tehran Iran (Islamic Republic of)