Cancer Diagnostic Probe

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 Cancer Diagnostic Probe product is specifically designed for this purpose. The Cancer Diagnostic Probe (CDP) 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 Cancer Diagnostic Probe 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 Cancer Diagnostic Probe (CDP) 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.

Scientific Advisors

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. CDP ( Cancer Diagnostic Probe ) 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 CDP 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 CDP to detect cancer cells in the internal margins (after tumor dissection) has the sensitivity and selectivity of 97% and 94%, respectively.

CDP Testimonials

Technical Data

CDP ( Cancer Diagnostic Probe ) in the Lymph Node Mode Involved lymph node detection is also performed based on measuring the impedimetric properties associated with Fatty Acid Oxidation (FAO), which is the most dominant cancer cell metabolism in the lymph node environment.

Hospitech Cancer Diagnostic Probe Standards

  • 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.
 

Hospitech Cancer Diagnostic Probe

Hospitech Cancer Care Innovations Company is leading the way in revolutionizing cancer diagnosis with its innovative range of devices. These include the Cancer Diagnostic Probe (CDP), Impedimetric Tumor Detection System (ITDS), Electrical Endoscopy Mass Detection (EMD), 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 Hospital Tech's breast cancer diagnostic product and benefit from an innovative and safe approach to breast tumor surgery and treatment.
  1. Applying an LN headprobe on an auxiliary lymph node to detect LN involvement
  2. Hematic view of a lymph node free of cancerous cells
  3. The metabolism of cancer cells in the primary tumor site based on taking glucose from blood vessels (hypoxia glycolysis)
  4. Schematic view of cancer cells spreading from the primary tumor site and invasion to a lymph node environment through lymphatic vessels
  5. With the metabolic shift of cancer cells to Fatty Acid Oxidation (FAO)
  6. Dimensions of an LN headprobe
Statistical Diagnostic Results of CDP ( Cancer Diagnostic Probe ) in the margin and Lymph nodes * Percentage reduction of the involved margins remaining in the patient’s body with the help of CDP despite performing Frozen-section and Permanent Pathology on tumor side margins (%)

Mohammad Abdolahad

Mohammad Abdolahad was born in Tehran, Iran, in 1982. He received his Ph.D. in Nanoelectronic Engineering from the University of Tehran in 2013. Immediately, he started teaching as an academic staff member in the College of Engineering, the School of Electrical and Computer Engineering. In the last few years, he has published more than 70 articles. He has 45 US patents in the field of cancer diagnosis and treatment devices ( Cancer Diagnostic Probe ). He has won many honors, including the Mustafa Award (2019), Selected Researcher of the Country (2019), Selected Young Researcher in 2017, etc.

CDP Articles

Case Reports

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US Patents

Iran IMED

Inida DCGI

Trial Phase

Oman MOH

Under Process

A cancer diagnostic probe 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 Cancer Diagnostic Probe

  • CDP in the margin mode

CDP›s detection mechanism in the margin mode has been based on real-time detection of released ROS/H2O, molecules by cancer cells during tumor initiation, reverse Warburg effect, and hypoxia-assisted glycolysis.

  • CDP in the lymph node mode

Involved lymph node detection is also performed based on measuring the impedimetric properties associated with Faxy Acid Oxidation (FAO), which is the most dominant cancer cell metabolism in the lymph node environment.

 

In the cancer diagnostic probe 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 Cancer Diagnostic Probe

  • 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

FAQ 

About the value you can compare it to old methods like as Frozen pathology. A standard frozen section service is around 300 USD (it is different in different countries and different hospitals) A normal general hospital performs around 20 surgeries in average. 50% of service belongs to doctor and 50% is hospitals’ share. It means around 150USD is hospitals share for using frozen pathology per order and 20 multiple 150 USD means 3000 USD per month revenue. Yearly it will be around 36.000 USD revenue and after 2 years the revenue will be around 72,000 USD. So if we consider CDP same as frozen pathology after 2 years device will return around 72.000 USD for a normal general hospital.
It needs some simple training sessions that should be held by the HOSPITECH Co. training department.
According to the surgeon’s evaluations, it can be used for every breast cancer patient or in some special categories including non-chemo-treated, chemo-treated, breast-conserving surgeries (BCS), extensive scattered DCIS patients, patients suspicious for nipple involvement
The product is innovative. The lack of such a solutions is proven and there is not any similar technology in Iran. The rate of breast cancer in Iran is high. Using CDP is not just a technology or business. It is life surviving solution and can save 3 of 10 patient’s life there.
Now all scientific societies believe in importance of cavity side and margin checking during the cancer surgery. And CDP is one of the leading products with highest accuracy in this field. Now CDP is transforming to be a Cancer Detection Platform for Surgeons for all Cancer surgeries.
As discussed in question 2, CDP is a highly-sensitive device that is unique in the detection of cavity side margin. It has about 93% sensitivity and 91% specificity in comparison with the gold standard (permanent pathology). Its head probes are disposable and cost-effective and have a very short response time. Several clinical trials with overall 8000 samples have been carried out by CDP until now.
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