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IRCT20190904044697N3 IRCT 2020-02-23 Iran Nano Fund Intra-operative real-time diagnostic system for suspicious breast tissue using electrochemical signaling as a complementary method for frozen section pathology CDP, Cancer Diagnostic Probe In-vivo intra-operative detection of breast margins involved in cancer using hypoxia glycolysis metabolism as neoplastic signaling. A frozen guided clinical trial 2020-02-04 anticipated 26 Complete https://irct.ir/trial/45991 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 the results of CDP. This categorization is 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 small and straightforward handheld equipment to increase the prognostic factor of the cancer patients, Randomization description: Twenty-six patients need to be recruited 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. 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. N/A Breast cancer surgery. Intervention group: The surgeon follows the standard guidelines based on frozen pathology, and will apply CDP as a complementary diagnostic tool to check the inner margins after completing the surgery (after checking and removing the involved margins through frozen results of external margins). Hence, when the margins are declared free after one or further sequences of frozen evaluation, the surgeon will use CDP on all internal margins. Frozen may report some tumor margins as involved external margins, which through standard guidelines, cavity side margins must be re-excised and resend for frozen up to be declared as free external margins by pathologists. In this clinical trial, the surgeon checks the internal lesions by CDP and inform the pathologist about the positively scored ones. Then, the pathologist further evaluates all over the last reciprocal external margin of that inner one by slide preparation from much more points on that margin. If the pathologist found any suspicious lesions in re-evaluation, he/she informs the surgeon to remove the positively scored margin. Otherwise, the surgeon wouldn't remove the CDP's positive reported margins, and we record the data of CDP responses. In the next step, the pathologist will recheck all of the last reciprocal external margins by permanent H&E. Hence, the patient will be recalled to undergone second surgery if any external margins have been missed by frozen and detected in permanent pathology either CDP has detected them or not.. Yes - There is a plan to make this available What will be shared: 80% 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 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) Iran (Islamic Republic of) Patients with noticeable breast tumor mass or previously diagnosed with solid mass (DCIS, ILC, IDC...). no limit no limit Both No exclusion regarding patients recruitment C50 Malignant neoplasm of breast Diagnosis Intervention group: The surgeon follows the standard guidelines based on frozen pathology, and will apply CDP as a complementary diagnostic tool to check the inner margins after completing the surgery (after checking and removing the involved margins through frozen results of external margins). Hence, when the margins are declared free after one or further sequences of frozen evaluation, the surgeon will use CDP on all internal margins. Frozen may report some tumor margins as involved external margins, which through standard guidelines, cavity side margins must be re-excised and resend for frozen up to be declared as free external margins by pathologists. In this clinical trial, the surgeon checks the internal lesions by CDP and inform the pathologist about the positively scored ones. Then, the pathologist further evaluates all over the last reciprocal external margin of that inner one by slide preparation from much more points on that margin. If the pathologist found any suspicious lesions in re-evaluation, he/she informs the surgeon to remove the positively scored margin. Otherwise, the surgeon wouldn't remove the CDP's positive reported margins, and we record the data of CDP responses. In the next step, the pathologist will recheck all of the last reciprocal external margins by permanent H&E. Hence, the patient will be recalled to undergone second surgery if any external margins have been missed by frozen and detected in permanent pathology either CDP has detected them or not. The pathological classification of different breast lesions correlates 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 3 days after the 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, Enghelab Ave. Tehran Tehran Iran (Islamic Republic of)