Accuracy of cancer diagnostic probe for intra-surgical checking of cavity side margins in neoadjuvant breast cancer cases: A human model study
Abstract
BACKGROUND: Background Recently, a real-time system, named cancer diagnostic probe (CDP), has been developed to diagnose the presence of pre-neoplastic/neoplastic cells in breast cavity side margins. Detecting mechanism is real-time determination of the ROS/H2 O2 released from cancer or atypical cells, through reverse Warburg effect and hypoxia glycolysis pathways.
AIMS: Here, we designed a human model study based on real-time checking of 387 internal margins (IM) from 39 neoadjuvant breast cancer cases by CDP. MATERIALS & METHODS: Each lesion was checked by entered needle sensor and electrical scores were recorded. The permanent pathology result of each tested lesion was our gold standard to evaluate CDP scoring. CDP results were compared with permanent pathology of tumour side margins (as a conventional margin evaluation procedure).
RESULTS: Results showed that the sensitivity of CDP in scoring the cavity side margins of those cases is 91%. A total of 18 involved IM which had been detected by CDP were declared as free margins in pathology section of tumour side samples. Just five involved IM were missed by CDP.
DISCUSSIONS: Such sensitivity revealed that metabolism based (here: hypoxia glycolysis) tracing of cancer cells show distinct electrochemical responses between clear and involved cavity side margin evaluation.
CONCLUSION: This human study showed the promising role of CDP to achieve clear margins after BCS of neoadjuvant cases.
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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