Microwave Imaging in Breast Cancer - Results from the First-In-Human Clinical Investigation of the Wavelia System.

RATIONALE AND OBJECTIVES: Microwave Breast Imaging (MBI) is an emerging non-ionising technology with the potential to detect breast pathology. The investigational device considered in this article is a low-power electromagnetic wave MBI prototype that demonstrated the ability to detect dielectric contrast between tumour phantoms and synthetic fibroglandular tissue in preclinical studies. Herein, we evaluate the MBI system in the clinical setting. The capacity of the MBI system to detect and localise breast tumours in addition to benign breast pathology is assessed. Secondly, the safety profile and patient experience of this device is established. MATERIALS AND METHODS: Female patients were recruited from the symptomatic unit to 1 of 3 groups: Biopsy-proven breast cancers (Group-1), unaspirated cysts (Group-2) and biopsy-proven benign breast lesions (Group-3). Breast Density was determined by Volpara VDM (Volumetric Density Measurement) Software. MBI, radiological, pathological and histological findings were reviewed. Subjects were surveyed to assess patient experience. RESULTS: A total of 25 patients underwent MBI. 24 of these were included in final data analysis (11 Group-1, 8 Group-2 and 5 Group-3). The MBI system detected and localised 12 of 13 benign breast lesions, and 9 out of the 11 breast cancers. This included 1 case of a radiographically occult invasive lobular cancer. No device related adverse events were recorded. 92% (n = 23) of women reported that they would recommend MBI imaging to other women. CONCLUSION: The MBI system detected and localized the majority of breast lesions. This modality may have the potential to offer a non-invasive, non-ionizing and painless adjunct to breast cancer diagnosis. Further larger studies are required to validate the findings of this study.

The Wavelia Microwave Breast Imaging system-tumour discriminating features and their clinical usefulness.

OBJECTIVE: The Wavelia Microwave Breast Imaging (MBI) system, based on non-ionising imaging technology, has demonstrated exciting potential in the detection and localisation of breast pathology in symptomatic patients. In this study, the ability of the system to accurately estimate the size and likelihood of malignancy of breast lesions is detailed, and its clinical usefulness determined. METHODS: Institutional review board and Health Products Regulatory Authority (HPRA) approval were obtained. Patients were recruited from the symptomatic unit to three groups; breast cancer (Group-1), unaspirated cysts (Group-2) and biopsied benign lesions (Group-3). MBI, radiological and histopathological findings were reviewed. MBI size estimations were compared with the sizes determined by conventional imaging and histopathology. A Quadratic Discriminant Analysis (QDA) classifier was trained in a 3D feature space to discriminate malignant from benign lesions. An independent review was performed by two independent breast radiologists. RESULTS: 24 patients (11 Group-1, 8 Group-2 and 5 Group-3) underwent MBI. The Wavelia system was more accurate than conventional imaging in size estimation of breast cancers. The QDA accurately separated benign from malignant breast lesions in 88.5% of cases. The addition of MBI and the Wavelia malignancy risk calculation was deemed useful by the two radiologists in 70.6% of cases. CONCLUSION: The results from this MBI investigation demonstrate the potential of this novel system in estimating size and malignancy risk of breast lesions. This system holds significant promise as a potential non-invasive, comfortable, and harmless adjunct for breast cancer diagnosis. Further larger studies are under preparation to validate the findings of this study. ADVANCES IN KNOWLEDGE: This study details the potential of the Wavelia MBI system in delineating size and malignancy risk of benign and malignant breast lesions in a symptomatic cohort. The usefulness of the Wavelia system is assessed in the clinical setting.

Spinal cord herniation after resection of cervical spinal neurofibroma with a unique presentation.

BACKGROUND CONTEXT: Spinal cord herniation (SCH) is a very rare condition. It was first reported in the lumbar spine in 1974. Thereafter, cases were reported in the thoracic and cervical spine occurring either spontaneously or after vertebral fracture, nerve root avulsion, and trauma surgery. PURPOSE: There is only one recorded case of SCH after tumor surgery. In this article, we reported the second case. STUDY DESIGN: We described the original surgical procedure, the clinical presentation, the operative repair, and the postoperative course. METHODS: No funding was required for this case report. RESULTS: The patient was a 56-years-old man, who presented with SCH 5 years after subtotal excision of a cervical neurofibroma. He presented with right upper monoparesis. CONCLUSIONS: To our knowledge, this presentation has not been reported previously in literature.