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IRCT20190904044697N1 IRCT 2019-10-01 Iran Nano Fund Intra-operative real-time diagnostic probe for suspicious legions using electrochemical tracing of hypoxia glycolysis CDP, Cancer Diagnostic probe Real-time intra-operative in-vivo diagnosis of internal margins involved to breast pre-invasive/invasive cancer cells through pathological classification using a handheld electrochemical system 2018-08-25 anticipated 200 Complete https://irct.ir/trial/41968 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Diagnostic, Other design features: The system lively determines the H2O2 released from cancer or atypical cells, through reverse Warburg effect and hypoxia assisted glycolysis pathways, in a quantitative electrochemical manner. We proposed a matched clinical diagnostic categorization between the pathological results of the tested tissues and response peaks of CDP based on ductal intraepithelial neoplasia (DIN) classification (with the latest reported modifications) based on our primary outcome results. Unique ability in the non-invasive and real-time diagnosis of internal margins with pathological values (from high-risk benign to pre-invasive and invasive cancer lesions) makes CDP a distinct intra-operative tool with simple and small handheld equipment to increase the prognostic factor of the cancer patients, Randomization description: We should select almost 200 patients from all categories of breast cancer for in-vivo tests. Among all types of breast cancers, patients with IDC tumors are more than other types (such as phylloids and lobular carcinomas). Our surgical collaborators randomly select and introduce the patients for this trial. Each patient who accepts to take part in the investigation will sign ethical consent. The number of patients needed for this project was determined by the ethics committee. However, we took permission to investigate more patients to ensure the reliability and repeatability of our results. N/A Breast cancer surgery. Intervention group: After tumor dissection, all the regions in body side margins named internal margins are tested by CDP. Depend on the size of the tumor and its proximity to one of the margins (not all the margins), some margins must undergo further analysis. The internal regions with more joint boundaries with the tumors would require further scans because of their larger formed internal margins. The head probe needles are single-used and the entered length of the needles into the breast margins are 4 millimeters. Scan region is 3*3*4 mm3 and if CDP score is positive, this area will be dissected for pathological examination.. 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: Starting 6 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 2 weeks. 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 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 Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with obvious breast tumor mass, previously diagnosed with solid mass (DCIS, ILC, IDC...). Neo-adjuvant cases with or without a wire guide. no limit no limit Both No exclusion regarding patients recruitment C50 Malignant neoplasm of breast, Breast cancer surgery, Hyperplasia Diagnosis Intervention group: After tumor dissection, all the regions in body side margins named internal margins are tested by CDP. Depend on the size of the tumor and its proximity to one of the margins (not all the margins), some margins must undergo further analysis. The internal regions with more joint boundaries with the tumors would require further scans because of their larger formed internal margins. The head probe needles are single-used and the entered length of the needles into the breast margins are 4 millimeters. Scan region is 3*3*4 mm3 and if CDP score is positive, this area will be dissected for pathological examination. Pathological classification of different breast lesions correlated with current peaks of CDP. Results show meaningful consistency between DIN (Ductal Intraepithelial Neoplasia) based pathological diagnosis and CDP scoring. Timepoint: Results will be compared with permanent pathology about 2 weeks after intervention. Method of measurement: Electrochemical Cyclic voltammetry. Iran Nano Fund Approved 2018-08-18 Ethics committee of Tehran University of Medical Science No.23, 16 Azar Ave, Tehran Ave., Tehran, Iran Postal Code: 1417863181 Tehran Tehran Iran (Islamic Republic of)