Breast Cancer Detector (BCD)
The Breast Cancer Detector (BCD): Breast cancer is a type of cancer that starts in the cells of the breast. It is one of the most common cancers in women worldwide, but it can also affect men. Breast cancer occurs when the cells in the breast grow uncontrollably, forming a tumor that can be detected through imaging or felt as a lump.
The main objective of Breast-Conserving Surgery (BCS) is to remove cancerous tumors with clear margins during the initial operation to avoid the need for additional surgery. If there are still cancerous cells at the edges of the removed tissue, there is a higher risk of the cancer coming back, leading to additional medical expenses and causing mental and physical stress.
Checking the margins of the surgical cavity immediately after tumor removal can help ensure that no cancerous cells are left behind, and the Breast Cancer Detector product is specifically designed for this purpose. The Breast Cancer Detector (BCD) is utilized in conjunction with frozen-section and permanent pathologies to identify high-risk pre-cancer/cancer cells in cavity side margins and cancerous cells in the lymph nodes of breast cancer surgery patients in real-time.
The Efficiency of Breast Cancer Detector in Breast Cancer
Directly checking the margins of the cavity after tumor excision can help prevent any remaining tumor residues, satellite, or scattered cancer cells. Published reports have indicated that conventional intraoperative methods, such as frozen section and X-ray evaluation of dissected tumor margins, still miss diagnosing more than 20% of the involved margins.
It is also important to remove all the involved lymph nodes from the body to reduce the risk of local recurrences. The Breast Cancer Detector (BCD) is a real-time diagnostic system that serves as a complementary surgeon-assisted tool. It is used in conjunction with frozen-section and permanent pathologies to detect high-risk pre-cancer/cancer cells in the cavity side margins and cancerous cells in the lymph nodes of patients undergoing breast cancer surgery.
In modern cancer therapy, these probes play a crucial role due to their precision and ability to provide detailed information about the presence and characteristics of cancer. This ultimately leads to improved diagnosis, treatment, and patient outcomes.
Breast Cancer Detector Description
Checking the cavity-side margins during surgery for breast cancer patients is critical to ensure the definitive removal of suspicious and high-risk lesions with minimal damage to normal tissue. Remaining cancer cells in the breast causes re-surgeries and inevitable post-surgical treatments, which will have several side effects. Frozen pathology of tumor margins during surgery is a clinically accepted procedure to guide the surgeon to any need for re-excision. However, the time-consuming and expert dependent process of margin examination and false diagnostics, especially in neoadjuvant cases, are limitations of this procedure. BCD ( Breast Cancer Detector ) system, has been introduced as a surgical assistant system in breast cancer surgery.
The new system reveals the cancerous cells in the internal margins (cavity-side margin) within a few millimeters in 40 seconds, using a needle sensor. This system has a clinical diagnostic classification matching with the pathological results of the tested tissues. The BCD response peaks are based on the classification of the pathological system (Ductal intraepithelial neoplasia (DIN), Lobular intraepithelial neoplasia (LIN), and Fibro epithelial lesion (FEL) (according to the latest reported revisions)).
The distinctive ability of BCD to detect cancer cells in the internal margins (after tumor dissection) has the sensitivity and selectivity of 97% and 94%, respectively.
Coosa Breast Cancer Detector
Coosa Cancer Care Innovations Company is leading the way in revolutionizing cancer diagnosis with its innovative range of devices. These include the Breast Cancer Detector (BCD), BIRADx System (BDS), Gastro-Intestinal Screening (GIS), and ElectroChemoTherapy (ECT) & Gamma Probe. These cutting-edge technologies are designed to improve cancer detection and treatment efficacy. Supported by research, articles, and patents, these tools provide accurate results for early diagnosis and better patient outcomes. The company takes pride in its dedicated team and unwavering commitment to making a significant impact in the healthcare industry’s fight against cancer.
Upgrade your medical center by utilizing Coosa’s breast cancer diagnostic product and benefit from an innovative and safe approach to breast tumor surgery and treatment.
- Applying an LN headprobe on an auxiliary lymph node to detect LN involvement
- Hematic view of a lymph node free of cancerous cells
- The metabolism of cancer cells in the primary tumor site based on taking glucose from blood vessels (hypoxia glycolysis)
- Schematic view of cancer cells spreading from the primary tumor site and invasion to a lymph node environment through lymphatic vessels
- With the metabolic shift of cancer cells to Fatty Acid Oxidation (FAO)
- Dimensions of an LN headprobe
Statistical Diagnostic Results of BCD ( Breast Cancer Detector ) in the margin and Lymph nodes
* Percentage reduction of the involved margins remaining in the patient’s body with the help of BCD despite performing Frozen-section and Permanent Pathology on tumor side margins (%)
TECHNOLOGY
A breast cancer detector offers advanced features, including high sensitivity for early detection and precision in identifying tumor margins. This technology has the potential to improve patient prognosis by enabling early intervention and reducing the need for additional surgeries, thus minimizing patient discomfort and treatment costs. Additional features of this device include the following:
Technology of Breast Cancer Detector (BCD) in the margin mode
BCDs detection mechanism in the margin mode has been based on real-time detection of released ROS/H2O2, molecules by cancer cells during tumor initiation, reverse Warburg effect, and hypoxia-assisted glycolysis.
a) Image of the BCD Margin HeadProbe in the margin mode, consisting of three needle
electrodes coated by multi-wall carbon nanotubes (MWCNTs).
b) Selective electrochemical reactions of released ROS/H2O2 on MWCNTs and production of
the electrochemical cathodic peak.
a) Applying an LN headprobe on an axillary lymph node to detect LN involvement.
b) Schematic view of a lymph node free of cancerous cells. c) The metabolism of cancer cells
in the primary tumor site based on taking glucose from blood vessels (hypoxia glycolysis).
d) Schematic view of cancer cells spreading from the primary tumor site and invasion to a
lymph node environment through lymphatic vessels. e) with the metabolic shift of cancer cells
to Fatty Acid Oxidation (FAO). f) Dimensions of an LN headprobe
The Breast Cancer Detector (BCD) employs an innovative detection mechanism that operates in margin mode, focusing on real-time monitoring of reactive oxygen species (ROS) and hydrogen peroxide (H2O2) molecules released by cancer cells. This approach capitalizes on the unique metabolic processes of tumors, particularly during tumor initiation and the reverse Warburg effect, where cancer cells alter their energy production to survive. By detecting these molecular changes, the BCD provides valuable insights into the presence of malignancies at the earliest stages, enhancing the accuracy of diagnosis while helping to delineate tumor margins during surgical procedures.
Furthermore, the BCD’s functionality extends to hypoxia-assisted glycolysis, a phenomenon frequently observed in rapidly growing tumors. By tracking the biochemical markers associated with this metabolic shift, the BCD not only identifies the cancerous tissues but also helps in distinguishing them from healthy cells. This level of precision aids surgeons in making informed decisions during operations, ultimately striving to improve patient outcomes by ensuring complete removal of cancerous tissue while preserving surrounding healthy structures. With its real-time capabilities, the BCD represents a significant advancement in the fight against cancer, paving the way for more targeted and effective interventions.
FEATURES
In the breast cancer detector device, we have incorporated the latest and most accurate techniques to detect and identify molecules released from cancer cells for real-time diagnosis with minimal margin of error. This identification process is carried out in two ways:
Features of Breast Cancer Detector
- Real-time and non-invasive detection of involved cavity side margins which are not detected by frozen-section pathology
- A diagnostic accuracy of over 93% during breast cancer surgery
- Real-time detection of involved lymph nodes with 91% sensitivity
- Reduction of about 30% of the involved cavity side margins
- Intraoperative diagnosis of excision-required newly discovered solid masses that were not evaluated in presurgical evaluations
- Increasing the prognosis factor and reducing the local recurrence rate in breast cancer patients.
- Using disposable head probes to prevent the transmission of contamination
ACHIEVEMENT
Coosa Breast Cancer Detector Stand
- IEC 60601-1: 2016: international Standard: General requirements for basic safety and essential performance for medical equipment.
- IEC 60601-1-2: 2014: EMC Compliance, General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances- Requirements and tests.
- ISO 62304: Medical Device software- Life cycle Process.
- ISO 10993-10: Biological evaluation of medical devices: Part 10: test for irritation and skin sensitization.
- ISO 10993-5: Biological evaluation of medical devices: Part 5: test for in- vitro cytotoxicity .
- ISO 11607-1: Packaging for terminally sterilized medical devices
- PART1: requirement for materials, sterile barrier systems, and packaging systems. INSO 3001-1: Sterility compliance
- ISO 13485: Medical Devices- Quality management systems.
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