Achieving optimized parameters for cancer treatment by electroporation method
Design
Patients are referred individually by specialist physicians according to the stated criteria for admission to the study and are treated by placing one or more needles around the tumor and stimulating the electroporation method. 40 patients are now ready to receive treatment in the hospital. Patients are aware of their treatment and the study is not capable of blinding.
Settings and conduct
After introducing the patient to this research and obtaining informed consent according to the patient's medical records and the location and type of tumor, the treatment protocol and the choice of reversible electroporation or electrochemotherapy should be selected. Then the type of electrodes, the number of stimulation doses of the drug required for complete treatment of the tumor is calculated. Then the electrodes are placed around the tumor and stimulation is performed according to the performed calculations.
Participants/Inclusion and exclusion criteria
Eligibility criteria:
• Radiological based on cancer in Stages IA, IB, IIA, IIB, IIIA, IIIB, IV
• Good performance (Karnofsky Score ≥ 70)
• Life expectancy of at least 3 months
Exclusion criteria:
• Pregnancy
Coagulation disorder (INR more than 1.5 times control)
• Platelets less than 100,000
• Anemia (hemoglobin less than 10)
• Serious acute infection
• Having an implanted pacemaker, defibrillator or deep brain stimulator or heart arrhythmias.
Intervention groups
1) The intervention group received electroporation in addition to the usual treatment
2) control group with usual treatment
Main outcome variables
Changes of tumors' size, alteration in microscopic and pathological characteristics and IHC markers of the tumor, changes in clinical manifestations, changes of different serum markers.
General information
Reason for update
Acronym
EP
IRCT registration information
IRCT registration number:IRCT20190904044697N8
Registration date:2022-10-02, 1401/07/10
Registration timing:registered_while_recruiting
Last update:2022-10-02, 1401/07/10
Update count:0
Registration date
2022-10-02, 1401/07/10
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
2022-10-01, 1401/07/09
Expected recruitment end date
2024-09-30, 1403/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to evaluate using electroporation system for treatment purposes and drug delivery to the tumor
Public title
Cancer treatment by electroporation method
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cancer patients who have different types of cancer with solid tumors.
cancer stage IA, IB, IIA, IIB, IIIA, IIIB, IV
(Karnofsky Score ≥ ۷۰)
Patients with different types of benign and malignant tumors
Exclusion criteria:
Pregnancy
Coagulation disorder (INR more than 1.5 times control)
Platelets less than 100,000
Anemia (hemoglobin less than 10)
Serious acute infection
Having an implanted pacemaker, defibrillator or deep brain stimulator or cardiac arrhythmias.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In the irreversible electroporation method, we only need to place one or more needles in the desired area and around the tumor, and after placing these needles, 80 to 100 pulses with a duration of 100 microseconds will be applied and finally the needles will be removed. In the reversible electroporation method, the chemotherapy drug, whose dosage and possibility of use have been checked before, is injected as IT or IV. 5 to 15 minutes after drug injection, it will be possible to apply stimulation, so during this time, we will place the electrodes in the right place and after this time, we will apply electrical pulses. Applying the pulse increases the permeability of the cell membrane and the cell will receive a much higher dose than usual. For example, according to reports, the penetration of bleomycin has increased up to 5000 times.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committees of Imam Khomeini hospital complex-Tehran University of Medical Sciences
Street address
North Amirabad - North Kargar Street - Above Jalal Al Ahmad Blvd - Opposite 9th Alley - Technical Faculty of Tehran University - Old building of Faculty of Electrical Engineering - Nanobioelectronics Laboratory
City
Tehran
Province
Tehran
Postal code
۵۱۵-۱۴۳۹۵
Approval date
2022-08-30, 1401/06/08
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.125
Health conditions studied
1
Description of health condition studied
Malignant cancer with solid tumor
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
2
Description of health condition studied
Benign tumor with solid mass
ICD-10 code
D24
ICD-10 code description
Benign neoplasm of breast
3
Description of health condition studied
Malignant cancer with solid tumor
ICD-10 code
C22
ICD-10 code description
Malignant neoplasm of liver and intrahepatic bile ducts
4
Description of health condition studied
Benign tumor with solid mass
ICD-10 code
D13.4
ICD-10 code description
Benign neoplasm of liver
5
Description of health condition studied
Malignant cancer with solid tumor
ICD-10 code
C77
ICD-10 code description
Secondary and unspecified malignant neoplasm of lymph nodes
6
Description of health condition studied
Malignant cancer with solid tumor
ICD-10 code
C78.0
ICD-10 code description
Secondary malignant neoplasm of lung
7
Description of health condition studied
Malignant cancer with solid tumor
ICD-10 code
C79.2
ICD-10 code description
Secondary malignant neoplasm of skin
8
Description of health condition studied
Malignant cancer with solid tumor
ICD-10 code
C73
ICD-10 code description
Malignant neoplasm of thyroid gland
9
Description of health condition studied
Malignant cancer with solid tumor
ICD-10 code
C56
ICD-10 code description
Malignant neoplasm of ovary
10
Description of health condition studied
Malignant cancer with solid tumor
ICD-10 code
C48
ICD-10 code description
Malignant neoplasm of retroperitoneum and peritoneum
11
Description of health condition studied
Malignant cancer with solid tumor
ICD-10 code
C22.1
ICD-10 code description
Intrahepatic bile duct carcinoma
12
Description of health condition studied
Malignant cancer with solid tumor
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon
13
Description of health condition studied
Malignant cancer with solid tumor
ICD-10 code
C15
ICD-10 code description
Malignant neoplasm of esophagus
Primary outcomes
1
Description
tumor size
Timepoint
Every two weeks
Method of measurement
Imaging modalities (Conventional ultrasound and especially Doppler ultrasound, MRI and CT scan)
2
Description
Clinical and quality of life changes
Timepoint
Every week
Method of measurement
Investigating of Clinical Manifestation
3
Description
Tumor cell death
Timepoint
every three month
Method of measurement
Immunostaining, Immunohistochemistry, H&E
4
Description
Metastasis to other organs
Timepoint
Every 6 month
Method of measurement
Imaging by MRI, CT or PET scan
Secondary outcomes
1
Description
Quality Of Life
Timepoint
90 days
Method of measurement
Questionnaire about quality of life indicators based on EORTC QLQ-C30
Intervention groups
1
Description
ABC Intervention group: Receiving electroporation in addition to the usual treatment. Definition of intervention: In cases where the tumor is inoperable, the patient will be assigned in the intervention group and will be treated with electroporation technique under the supervision of the surgeon in the following two cases: 1) Tumor through the skin can receive the electroporation technique and does not require open surgery. 2) In order to reach the tumor site, before receiving the electroporation technique, surgery should be performed to access the tumor and then the technique should be performed for the patient during the operation. In each treatment group, the patients received bleomycin with a dose of 1000 IU/ml and manufactured by the company. BDR Pharmaceuticals India and intravenously or intratumorally, eight minutes before electroporation. Then, electric pulses are inserted into the tumoral tissue through electrodes made of 316 stainless steel, which are biocompatible and have a medical grade, and with a thickness of 300 micrometers, which are either needles or plates, depending on the size of the tumor and the discretion of the study leader. Establishing electric pulses with a field intensity of 100 V/cm to 2000 V/cm and with a width of 1 to 100 microseconds and an alternating number of pulses will create holes in the cell membrane to increase the permeability of bleomycin. The pulse generating device is made in Iran by Nano Hesgarsazan Salamat Arya Company.
Category
Treatment - Devices
2
Description
Control group: In this group, patients receive only the standard and routine treatment prescribed by a specialist doctor.
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
Other
Person responsible for general 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 oncosurgery 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 oncosurgery 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 updating data
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 oncosurgery 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
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
Yes - There is 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 main outcome, can be shared
When the data will become available and for how long
Available 6 months after the paper has been published.
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, imaging reports and serum markers by request.
What processes are involved for a request to access data/document
The data will be sent to the applicant within two weeks after the request.