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.

Diagnostic imaging of deep vein thrombosis secondary to osteochondroma formation.

Deep vein thrombosis (DVT) is a condition classically associated with blood stasis, hypercoagulability or injury to the vasculature. As blood stasis is usually associated with patient immobility, DVT occurrence in young active patients with no underlying haematological conditions is a rarity. An exostosis, also known as osteochondroma, is a cartilage capped lesion. If solitary, they represent low malignant potential and unless symptomatic, they are rarely excised. A 23-year-old, active male, presented to hospital with pain and swelling in the left lower leg. It was a deep, non-radiating pain, exacerbated by exercise. Wells' criteria score for DVT was 2. An ultrasound was performed which identified thrombosis in the superficial femoral, and popliteal veins. Haematological causes of thrombosis were ruled out. X-ray showed a posterior femoral exostosis. It was determined that compression by the exostosis was the cause of the thrombosis. We present a case of a DVT secondary to osteochondroma formation in a young male. Isolated DVT in this setting is uncommon with fewer than five previously reported cases identified in the literature. We also discuss the current literature and management of this rare entity.

Does percutaneous transluminal angioplasty improve quality of life?

PURPOSE: To prospectively assess the impact of peripheral percutaneous transluminal angioplasty (PTA) on quality of life (QOL) in patients with intermittent claudication or critical limb ischemia (CLI). The secondary purpose was to determine if periprocedural medication altered patient QOL. MATERIALS AND METHODS: A total of 72 patients underwent lower-limb PTA (86 lesions) over a period of 12 months. QOL data were obtained before PTA and at 1 and 6 months after PTA with use of the Short Form-36 (SF-36) questionnaire. RESULTS: The SF-36 questionnaire was completed in 100% of cases before PTA, in 89% at 1 month after PTA, and in 78% at 6 months after PTA. Baseline QOL was worse than the QOL quoted for the normal population. Overall, there was an improvement in QOL in seven of the nine health domains at 1 month after PTA, and the improvements were significant (P < .01) in five. Improvement was demonstrated at 6 months in all nine QOL domains measured, which was significant (P < .01) in five. Patients with intermittent claudication (n = 40) exhibited an improvement in all nine health domains at 6 months, which was significant (P < .05) in seven. The CLI group (n = 32) showed an improvement in five domains at 6 months, which was significant (P < .05) in two. Subjects with intermittent claudication experienced a more significant improvement than those with CLI. SF-36 pain scores at 1 month after PTA were significantly better in patients taking aspirin than in those who were not (P < .001). CONCLUSIONS: PTA results in improved QOL in patients with intermittent claudication and CLI as early as 1 month, which was shown to be maintained at 6 months in our small series. Aspirin significantly improves pain after PTA. QOL assessment is useful after peripheral angioplasty.

Can classic metaphyseal lesions follow uncomplicated caesarean section?

BACKGROUND: Classic metaphyseal lesion (CML) is the term given to a fracture that most often occurs in the posteromedial aspect of the distal femur, proximal tibia, distal tibia, and proximal humerus in infants; this finding is strongly associated with non-accidental injury. OBJECTIVE: To demonstrate that the CML may occur following simple lower segment caesarean section (LSCS). MATERIALS AND METHODS: A review of 22 years of an obstetric practice that delivers 8,500 babies per year. RESULTS: We identified three neonates born by elective LSCS, each with distal femoral metaphyseal fractures on postpartum radiographs. All caesarean sections were elective and uncomplicated. External cephalic version was not employed preoperatively. Postpartum radiographs demonstrated a fracture of the distal femoral metaphysis in each neonate, typical of a CML. CONCLUSION: We propose that a CML can occur in the setting of a simple, elective and uncomplicated LSCS where no external cephalic version is employed.