Background Nodal status evaluation is a crucial step in determining prognostic factors and managing treatment strategies for breast cancer patients. Preoperative (CNB), intraoperative (SLNB), and even postoperative techniques (Formalin-Fixed Paraffin-Embedded sectioning, FFPE) have definite limitations of precision or sometimes are time-consuming for the result declaration. The primary purpose of this prospective study is to provide a precise complementary system for distinguishing lymph nodes (LNs) involved by cancerous cells in breast cancer patients intraoperatively. Methods The proposed system, Electrical Lymph Scoring(ELS), is designed based on the dielectric properties of the under-test LNs. The system has a needle-shaped 2-electrode probe entered into SLNs or ALNs dissected from patients through standard surgical guidelines. Impedance magnitude in f = 1 kH (Z1kHz) and Impedance Phase Slope in frequency ranges of 100 kHz–500 kHz (IPS) were then extracted from the impedance spectroscopy data in a cohort study of 77 breast cancer patients(totally 282 dissected LNs) who had been undergone surgery before (n = 55) or after (n = 22) chemical therapies (non-neoadjuvant or neoadjuvant chemotherapy). A new admittance parameterSymbol also proposed for LN detection in neoadjuvant chemotherapy patients. Results Considering the permanent pathology result as the gold standard checked by two independent expert pathologists, a significant correlation was observed between the presence of cancerous cells in LNs and individual ranges of the ELS electrical responses. Compared with normal LNs containing fatty ambient and immune cells, LNs involved by cancerous clusters would reduce the Z1kHz and increase the IPS. These changes correlate with fat metabolism by cancer cells due to their Fatty Acid Oxidation (FAO) in LN, which results in different dielectric properties between high and low-fat content of normal and cancerous LNs, respectively. Conclusions By finding the best correlation between our defined impedimetric parameters and pathological states of tested LNs, a real-time intraoperative detection approach was developed for highly-sensitive (92%, P<0.001) diagnosis of involved sentinel or axillary LNs. The impact of real-time intraoperative scoring of SLNs would make a pre-estimation about the necessity of excising further LNs to help the surgeon for less invasive surgery, especially in the absence of frozen-section equipment. Graphical abstract Highlights
Evaluating a real-time complementary bioelectrical diagnostic device based on electrical impedance spectroscopy (EIS) for improving breast imagingreporting and data system (BI-RADS) scoring accuracy, especially in high-risk or borderline breast diseases. The primary purpose is to characterize breast tumors based on their dielectric properties. Early detection of high-risk lesions and increasing the accuracy of tumor sampling and pathological diagnosis are secondary objectives of the study. Methods: The tumor detection probe (TDP) was first applied to the mouse model for electrical safety evaluations by electrical current measurement. Then it was utilized for characterization of 138 human palpable breast lesions that were to undergo core needle biopsy (CNB), vacuum-assisted biopsy (VAB), or fine needle aspiration (FNA) on the surgeon's requests. Impedance phase slope (IPS) in frequency ranges of 100-500 kHz and impedance magnitude in f = 1 kHz were extracted as the classification parameters. Consistency of radiological and pathological declarations for the excisional recommendation was then compared with the IPS values. Results: Considering pathological results as the gold standard, meaningful correlations between IPS and pathophysiological status of lesions recommended for excision (such as atypical ductal hyperplasia, papillary lesions, complex sclerosing adenosis, and fibroadenoma) were observed (p < 0.0001). These pathophysiological properties may include cell size, membrane permeability, packing density, adenosis, cytoplasm structure, etc. Benign breast lesions showed IPS values greater than 0, while high-risk proliferative, precancerous, or cancerous lesions had negative IPS values.Statistical analysis showed 95% sensitivity with area under the curve (AUC) equal to 0.92. Conclusion: Borderline breast diseases and high-risk lesions that should be excised according to standard guidelines can be diagnosed with TDP before any sampling process. It is an important outcome for high-risk lesions that are radiologically underestimated to BI-RADS3, specifically in younger patients with dense breast masses that present challenges in mammographic and sonographic evaluations. Also, the lowest IPS value detects the most pathologic portions of the tumor for increasing sampling accuracy in large tumors.
Background:Before primary percutaneous coronary intervention (PCI) in patients with ST elevation myocardial infarction (STEMI), it is not clear whether a routine early administration of glycoprotein IIb/IIIa inhibitors in the emergency ward is beneficial or their administration in selected cases in the catheterization laboratory.Objectives:The present randomized clinical trial sought to investigate whether an earlier administration of Tirofiban could exert any impact on TIMI grade 3 flows and ST resolution in the electrocardiography of patients with STEMI before primary PCI.Materials and Methods:Patients with STEMI within twelve hours of symptom commencement were included if primary PCI was planned to be performed within ninety minutes of admission and excluded if they had contraindications for Tirofiban. Seventy patients were randomized to receive 25 μg/kg of bolus Tirofiban early in the emergency ward (the early Tirofiban group) in three minutes and 70 did not receive Tirofiban (the control group). The primary endpoint of the study was a Thrombolysis in Myocardial Infarction (TIMI) grade 3 flows on the initial angiogram. The study is registered as IRCT201105126463N1 in: www.irct.ir.Results:The study population had a mean age of 57.17 ± 10.09 years and included 79.3 % males. TIMI grade 3 flow was seen in 15 (21.4 %) patients of the Tirofiban group and 7 (10 %) of the control group (P = 0.06, odds ratio = 0.407, and 95 % confidence interval = 0.155-1.072). Complete ST resolution was seen in 30 (42.9 %) patients of the Tirofiban group and 34 (48.6 %) of the control group (P = 0.5).Conclusion:Although TIMI grade 3 flows trended to be higher in the patients who received early Tirofiban in the emergency ward, the difference did not constitute statistical significance and possible benefits, therefore, require further clarification.
A gigahertz (GHz) range antenna formed by a coaxial probe has been applied for sensing cancerous breast lesions in the scanning platform with the assistance of a suction tube. The sensor structure was a planar central layer and a metallic sheath of size of 3 cm2 connected to a network analyzer (keySight FieldFox N9918A) with operational bandwidth up to 26.5 GHz. Cancer tumor cells have significantly higher water content (as a dipolar molecule) than normal breast cells, changing their polarization responses and dielectric losses to incoming GHz-based stimulation. Principal component analysis named S11, related to the dispersion ratio of the input signal, is used as a parameter to identify malignant tumor cells in a mouse model (in vivo) and tumor specimens of breast cancer patients (in vitro) (both central and marginal parts). The results showed that S11 values in the frequency range from 5 to 6 GHz were significantly higher in cancer-involved breast lesions. Histopathological analysis was the gold standard for achieving the S11 calibration to distinguish normal from cancerous lesions. Our calibration on tumor specimens presented 82% positive predictive value (PPV), 100% negative predictive value (NPV), and 86% accuracy. Our goal is to apply this system as an in vivo non-invasive tumor margin scanner after further investigations in the future.
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