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IRCT20190904044697N8 IRCT 2022-10-02 Iran Nano Fund Cancer treatment by electroporation method EP A clinical trial to evaluate using electroporation system for treatment purposes and drug delivery to the tumor 2022-10-01 anticipated 70 Complete https://irct.ir/trial/63215 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A Condition 1: Malignant cancer with solid tumor. Condition 2: Benign tumor with solid mass. Condition 3: Malignant cancer with solid tumor. Condition 4: Benign tumor with solid mass. Condition 5: Malignant cancer with solid tumor. Condition 6: Malignant cancer with solid tumor. Condition 7: Malignant cancer with solid tumor. Condition 8: Malignant cancer with solid tumor. Condition 9: Malignant cancer with solid tumor. Condition 10: Malignant cancer with solid tumor. Condition 11: Malignant cancer with solid tumor. Condition 12: Malignant cancer with solid tumor. Condition 13: Malignant cancer with solid tumor. Intervention 1: 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. Intervention 2: Control group: In this group, patients receive only the standard and routine treatment prescribed by a specialist doctor. Yes - There is a plan to make this available What will be shared: 60% of the information about the main outcome, can be shared When: Available 6 months after the paper has been published. 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, imaging reports and serum markers by request. How to obtain: The data will be sent to the applicant within two weeks after the request. Comments:
public 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
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 Iran (Islamic Republic of) Iran (Islamic Republic of) 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 no limit no limit Both 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. C50 D24 C22 D13.4 C77 C78.0 C79.2 C73 C56 C48 C22.1 C18 C15 Malignant neoplasm of breast Benign neoplasm of breast Malignant neoplasm of liver and intrahepatic bile ducts Benign neoplasm of liver Secondary and unspecified malignant neoplasm of lymph nodes Secondary malignant neoplasm of lung Secondary malignant neoplasm of skin Malignant neoplasm of thyroid gland Malignant neoplasm of ovary Malignant neoplasm of retroperitoneum and peritoneum Intrahepatic bile duct carcinoma Malignant neoplasm of colon Malignant neoplasm of esophagus Treatment - Devices Treatment - Devices 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. Control group: In this group, patients receive only the standard and routine treatment prescribed by a specialist doctor. Tumor size. Timepoint: Every two weeks. Method of measurement: Imaging modalities (Conventional ultrasound and especially Doppler ultrasound, MRI and CT scan). Clinical and quality of life changes. Timepoint: Every week. Method of measurement: Investigating of Clinical Manifestation. Tumor cell death. Timepoint: every three month. Method of measurement: Immunostaining, Immunohistochemistry, H&E. Metastasis to other organs. Timepoint: Every 6 month. Method of measurement: Imaging by MRI, CT or PET scan. Quality Of Life. Timepoint: 90 days. Method of measurement: Questionnaire about quality of life indicators based on EORTC QLQ-C30. Iran Nano Fund Approved 2022-08-30 Research ethics committees of Imam Khomeini hospital complex-Tehran University of Medical Sciences 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 Tehran Tehran Iran (Islamic Republic of)