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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

Protocol summary

Study aim
Differentiation of benign and malignant thyroid lesions in patients candidate for surgery and assistance in the diagnosis of lesions with non-diagnostic FNA and AUS.
Design
A pragmatic, single group, not blinded, not randomized, an intervention group, sample size 384 patients.
Settings and conduct
Considering inclusion and exclusion criteria, a double-layer sterilized G18-G22 needle is inserted into the solid mass or suspicious lymph node in the surgery room. Then a low power electrical signal of varying frequency is applied between the inner and outer needles of the probe. The electrical impedance is then measured and classification parameters are determined by analyzing phase and impedance diagrams for distinguishing benign and malignant lesions. The probe is inserted in the thyroid nodule under the sonography guidance and measurement is accomplished.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with thyroid lesions candidate for total thyroidectomy of lobectomy, patients candidate for parathyroid surgery, patients candidate for lymph node dissection, patients candidate for Thyroid or neck lymph nodes biopsy No exclusion criteria for patients candidate for Thyroid surgery High blood pressure patients or patients taking anticoagulants (for ETS tests before biopsy)
Intervention groups
Biopsy candidates: a G18 modified sterilized needle is inserted into the tissue under the sonography guidance, before the biopsy and the impedance data is recorded. Surgery candidates: before excision of the thyroid nodule and suspicious lymph nodes, the needle is inserted into the tissue.
Main outcome variables
Real-time distinguishment of benign and malignant thyroid lesions, metastatic lymph node detection, parathyroid tissue detection, and cancer type evaluation if possible (medullary, papillary, and follicular)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190904044697N7
Registration date: 2021-02-16, 1399/11/28
Registration timing: prospective

Last update: 2021-02-16, 1399/11/28
Update count: 0
Registration date
2021-02-16, 1399/11/28
Registrant information
Name
Mohammad Abdolahad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 8367
Email address
m.abdolahad@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Thyroid Electrical Impedance Spectroscopy
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 384
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
No.23, 16 Azar Ave, Enghelab Ave,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1417863181
Approval date
2018-08-18, 1397/05/27
Ethics committee reference number
IR.TUMS.VCR.REC.1397.355

Health conditions studied

1

Description of health condition studied
Malignant neoplasm of Thyroid
ICD-10 code
C73
ICD-10 code description
Malignant neoplasm of Thyroid

2

Description of health condition studied
Benign tumor with solid mass
ICD-10 code
D34
ICD-10 code description
Benign neoplasm of thyroid gland

3

Description of health condition studied
Secondary and unspecified malignant neoplasm of lymph nodes of head, face and neck
ICD-10 code
C77.0
ICD-10 code description
Secondary and unspecified malignant neoplasm of lymph nodes of head, face and neck

Primary outcomes

1

Description
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)

Secondary outcomes

1

Description
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

Intervention groups

1

Description
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.
Category
Diagnosis

2

Description
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.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Mohammad Abdolahad
Street address
Tajrish sq.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
pr_shohada@sbmu.ac.ir
Web page address

2

Recruitment center
Name of recruitment center
Ghamar Bani Hashem Hospital
Full name of responsible person
Mohammad Abdolahad
Street address
Resalat Highway
City
Tehran
Province
Tehran
Postal code
1661649861
Phone
+98 21 2286 8885
Email
m.abdolahad@ut.ac.ir
Web page address

3

Recruitment center
Name of recruitment center
Resalat Hospital
Full name of responsible person
Mohammad Abdolahad
Street address
Resalat Ave.
City
Tehran
Province
Tehran
Postal code
166163781
Phone
+98 21 2286 8885
Email
m.abdolahad@ut.ac.ir
Web page address
http://ghamarhospital.ir/

4

Recruitment center
Name of recruitment center
Tirad Radiology Center
Full name of responsible person
Mohammad Abdolahad
Street address
Ghaem Magham Farahani
City
Tehran
Province
Tehran
Postal code
1586736513
Phone
+98 21 8871 6511
Email
m.abdolahad@ut.ac.ir
Web page address
https://tiradsono.com/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran Nano Fund
Full name of responsible person
Dr Mohammad Hosein Bahreini
Street address
No. 38, West Nastaran Ave (Arab), Khorramshahr St., North Sohrevardi St., Tehran
City
Tehran
Province
Tehran
Postal code
1533984611
Phone
+98 21 8876 9188
Email
info@nanofund.ir
Web page address
http://nanofund.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran Nano Fund
Proportion provided by this source
70
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Abdolahad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Electrotechnical specialist in onco-surgery and cancer therapy
Street address
Nano bio electronic lab, ground floor, school of electrical and computer engineering, university of Tehran faculty of engineering, North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1439957131
Phone
+98 21 8802 8367
Email
m.abdolahad@ut.ac.ir
Web page address
https://nbel.ut.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Abdolahad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Electrotechnical Specialist in onco-surgery and cancer therapy
Street address
North Kargar Ave
City
Tehran
Province
Tehran
Postal code
14395/515
Phone
+98 21 8802 8367
Email
m.abdolahad@ut.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Abdolahad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Cancer Specialist
Street address
Nano bio electronic lab, ground floor, school of electrical and computer engineering, university of Tehran faculty of engineering, North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1439957131
Phone
+98 21 8802 8367
Email
m.abdolahad@ut.ac.ir
Web page address
https://nbel.ut.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
60% of the information about the primary outcome after de-identifying the participants, can be shared.
When the data will become available and for how long
Starting six months after publication.
To whom data/document is available
The data will be available for medical staff and academic institutions
Under which criteria data/document could be used
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.
From where data/document is obtainable
Applicants can request data access via email. The data will be available to the applicant in a categorized manner with pathology reports.
What processes are involved for a request to access data/document
We will send the data to the applicant in one week.
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