BackgroundReceiving real-time information on tissue properties while performing biopsy procedures has the potential of improving biopsy accuracy. The study goal was to test the ability of a miniature flexible Radio-Frequency (RF) sensor (Dune Medical Devices), designed to be mounted on the surface of surgical tools, in measuring and mapping the various breast tissue types and abnormalities in terms of electrical properties.MethodsBetween January and October 2012, 102 patients undergoing lumpectomy, open-biopsy or mastectomy, in 3 medical centers, were enrolled in this study. The device was applied to freshly excised specimens, with registration between device measurements and histology analysis. Based on histology, the dielectric properties of the various tissue types were derived. Additionally, the ability of the device to differentiate between malignant and non-malignant tissue was assessed.ResultsA total of 4322 measurements from 106 specimens from 102 patients were analyzed. The dielectric properties of 10 tissue types in the low RF-frequency range were measured, showing distinct differences between the various types. Based on the dielectric properties, a score variable was derived, which showed a correlation of 90 % between the RF measurements and the tissue types. Differentiation ability between tissue types was characterized using ROC curve analysis, with AUC of 0.96, and sensitivity and specificity of 90 and 91 % respectively, for tissue feature sizes at or above 0.8 mm.ConclusionsUsing a radio-frequency near-field spectroscopy miniature flexible sensor the dielectric properties of multiple breast tissue types, both normal and abnormal, were evaluated. The results show promise in differentiating between various breast tissue types, and specifically for differentiation between cancer and normal tissues.

HighlightsA case report of postoperative ileo-ileal intussusception with a sutured enterotomy site as a lead point is described.This is a rare postoperative complication in the adult.A review of the relevant literature is presented.

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Background: The study goal was to test the ability of a miniature flexible RF sensor (Dune Medical Devices), designed to be mounted on the surface of surgical tools, in measuring and mapping the various breast tissue types in terms of electrical properties. This study was part of the first stage in developing a measuring device for use during biopsy procedures. Methods: One hundred and two (102) patients undergoing lumpectomy, open biopsy or mastectomy in 3 medical centers between January and October 2012 were enrolled in this study. The device was applied to numerous sites of freshly excised specimens. Measurement sites were accurately marked, to ensure registration between device measurement and histology analysis. The dielectric properties of the various tissue types were derived from matching between measurements and histology. The correlation between device readings and tissue type, as well as the ability of the device to differentiate between malignant and non-malignant sites, was assessed. Results: A total of 4322 measurements from 102 patients were analyzed. The dielectric properties of 10 tissue types in the low RF frequency (4-30MHz) range were measured, showing distinct differences between the various types. The correlation between the RF measurements, as quantified by a score variable, and the tissue types, is demonstrated, with a correlation coefficient of 0.90 (95% CI: 0.89 - 0.91). Differentiation ability between tissue types is also demonstrated using ROC curve analysis, with AUG of 0.96 (95% CI: 0.95 - 0.97), and sensitivity and specificity of 90.2% (95% CI: 84 - 95) and 90.9% (95% CI: 90 - 92), respectively, at feature sizes at or above 0.8 mm in diameter. Conclusions: First results from a radio-frequency near-field spectroscopy miniature flexible sensor evaluate the dielectric properties of various breast tissue types. The results also show promise in differentiating between various breast tissue types, and specifically for differentiation between cancer and normal tissues. The sensor's dimensions (radius of ∼1mm) and flexible design enable use in lumpectomy procedures (for margin assessment) as well as in minimally invasive devices and breast biopsy. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P4-03-02.

Background: With approximately 1.6 million annual procedures in the United States and 3 million world-wide, needle biopsy is considered the Gold Standard for breast cancer diagnosis and treatment planning. Overdiagnosis can result in unnecessary treatment, cost, and anxiety, while underdiagnosis can delay treatment and diminish outcomes. A 2015 study published in JAMA1 found nearly 25% discordance between pathology diagnosis and expert review, most pronounced in cases of DCIS, Atypia and in patients with dense breasts. It has been well established that physiologic differences between benign and malignant tissues are reflected in their electrical properties.2,3,4 Access to real-time tissue properties during the biopsy procedure has the potential for increasing accuracy by enabling the most suspicious tissue to be sampled, and by providing the tissue characterization to pathology for comparison with histologic findings. Through research made possible by the European Union’s Horizon 2020 research award, this feasibility study sought to determine if five 0.8mm miniaturized, flexible RF sensors (Dune Medical Devices, Alpharetta, GA) mounted within the sample cavity of a 14-gauge biopsy needle can accurately measure and map the electrical properties of multiple breast tissue types. Methods: Between March, 2018 and March, 2019, 44 patients undergoing mastectomy or lumpectomy at three medical centers in Israel were enrolled in the study. The biopsy needle was applied to freshly excised specimens, with continuous readings by the sensors. An average of 8.1 cores (ranging from 2-10) were obtained from each specimen. Cores were oriented and analyzed by standard histopathology. Based on histology, the dielectric properties of the various tissue types were derived, and the ability of the device to differentiate between malignant and non-malignant tissue was assessed. Results: A total of 357 cores from 44 specimens were analyzed. Ease of use and quality of tissue samples were equivalent to that of a standard biopsy needle. The dielectric properties of three tissue groups: Fat, Healthy non-Fat, and Malignant, in the low radiofrequency range were measured, showing distinct differences between the various types. Feature sizes larger than 0.8 mm were analyzed. The differentiation ability between tissue types was characterized using sensitivity and specificity of 85% and 99% respectively. Conclusions: Miniature, flexible RF sensors can be incorporated onto a biopsy needle. Although this study utilized a 14-gauge core needle, the 0.8mm sensor size allows for configuration within both vacuum-assisted and core biopsy needles of various gauges. The dielectric properties of breast tissue can be assessed in real-time during the biopsy procedure. These results show promise in differentiating between breast tissue types, specifically cancerous and benign, enabling more accurate tissue sampling and subsequent diagnosis. Improving the accuracy of breast biopsies should provide immediate clinical impact by reducing overstaging and subsequent unneeded treatment, procedures and cost, as well as reducing understaging of breast cancer which results in delayed diagnosis and missed cancer. Forward-looking, real-time tissue characterization during biopsy could prove especially beneficial should newer protocols currently under trial, such as active surveillance for low risk DCIS5 and omission of surgery for exceptional responders of neoadjuvant chemotherapy,6 become treatment options. The ability to mount the sensors to minimally invasive treatment devices will lay the foundation for expanding the technology to other cancer types, with the potential for precision delivery of new targeted drugs, radiation and ablation therapies at the site of the cancer. Citation Format: Noemi Weisenberg, Avihai Lachman, Lisa Cadena, Inbal Shimens, Olga Shmain, Ahuva Grubstein, Yael Rapson, Hana Cernik, Debora Kidron, Tania Zehavi, Evgeny Edelstein, Vladimir Kravtsov, Tatiana Kogan, Meirav Wolff Bar, Judith Diment, Ilana Haas, Patricia Malinger, Eran Sharon, Yehudit Birnbaum, Ada Magen, Yael Sobol, Osnat Givon Madhala, Sonya Wadhawker, Tanir M Allweis. Feasibility of incorporating miniaturized, flexible radiofrequency (RF) sensors in a breast biopsy needle for accurate real-time characterization of benign and malignant tissue [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr OT3-04-01.