CDP FAQs (Helpie 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 japan. The rate of breast cancer in Japan 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.    

  Breast surgeons, Breast cancer patients, All Cancer surgeons    

  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.  

  It is necessary for the surgeon to scan the whole cavity side by CDP and without bias, otherwise, if the surgeon does not follow the usage guideline, some involved margins may remain in the body. Also, there have not been any reported side effects by the surgeon and patients in more than 5 years of CDP usage in the hospitals. And CDP now developed for Lymph and mass affected detection and also test result succeeded for Gastrointestinal cancers and its under getting certification to enter to the market.  

  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.

  Precision, more than 35% improvement in detection of involved margins in comparison with conventional methods, portability, simple use, disposable cost-effective head probes.       Based on the CDP Clinical Trail 7 results, CDP could detect 56 neoplastic lesions intraoperatively (54%), whereas the conventional method (Frozen section and Permanent pathology) just diagnosed about 26 of those lesions. Also, it could cover about 95%, and 100% of high-risk and low-risk lesions based on the breast pathological calibration.    

  The gold standard for the evaluation of CDP scores is permeant pathology of cavity side margins. CDP works based on permanent pathology as the gold standard and is not a prognostic device. Since all involved margins should be resected from the patient’s body according to breast cancer surgical guidelines, and CDP is calibrated with permanent pathology, positive cavity side margins are recommended to dissect. As can be seen from the table, a reduction of about 30% 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 occurred. Remaining positive margins in breast-conserving surgery are associated with an increased risk of local recurrence, leading to healthcare costs and mental and physical stress. Direct checking of cavity side margins after tumor excision may prevent the tumor bed from remaining tumor residues/satellite/scattered cancer cells. Published reports indicated that more than 20% of the involved margins, still couldn’t be diagnosed intra-operatively by conventional intra-operative methods such as frozen section and X-ray evaluation of dissected tumor margins. It is also necessary to take all the involved lymph nodes out of the body to decrease the risk of local recurrences. Cancer Diagnostic Probe (CDP), a real-time diagnostic system as a complementary surgeon-assisted tool, along with Frozen-section and Permanent pathologies, is used to detect high-risk pre-cancer/cancer cells in the cavity side margins and cancerous cells in lymph nodes of patients undergoing breast cancer surgery.  

CDP is now used in about 100 hospitals and cancer research centers. It is currently under clinical trials to become registered in the Indian and Omani Health Ministry. We are also navigating with Brazilian surgeons to start clinical trials in Brazil.

   

• Seeding: if the surgeon uses a probe with previous positive responses in one another margin
• Improper use: if the surgeon does not follow the usage guideline, some involved margins may remain in the body.
• Infection: CDP Head probes are sterilized and disposable. So, the infection may not be a concern.

   

  Results of CDP are not affected by the morphology, grading, size of the tumor, breast density, age, BMI, or the use of marker wires. The system works based on different biological metabolisms of cancer cells and detects paraneoplastic/neoplastic (from ADH to IDC) cells in the cavity side margin, after tumor removal.  

  The system’s function and role is to find cancerous cells remaining in the cavity side margins. It means it can be used for breast cancer patients who are diagnosed with CNB in preclinical evaluations. Invasive cancer cells of the tumor margin can escape from the tumor edges and make clustered scattered tumoral cells or satellite lesions in the peripheral tissues. These clusters can’t be easily detected by the surgeon intraoperatively. On the other hand, they are not being evaluated by any conventional pathological method. So, having a precise device that can be applied simply in the cavity side margins, can help to excise involved tissues in the internal margins. If the involved margins remain in the body, cancer recurrence probability may increase and the survival rate may decrease. So, please note that the CDP function is not detecting the tumor type/grade, but it only detection of paraneoplastic/neoplastic (from ADH to IDC) cells in the cavity side margin.  

 

• First of all, the system works based on different biological metabolisms of cancer cells.
• Then, the system evaluation is performed on cavity side margins which are not routinely examined by pathological methods (frozen-section and permanent) and remain in the body without any evaluations.
• CDP evaluation is not only on the margin surface and has a 4mm depth of sensitivity.
• All the calibrations are performed based on the cavity side margin permanent pathology results.
• 8000 samples from 600 different patients of all types and grades of breast cancer tumors have been tested in three clinical trials.
• Accordingly, scattered tumoral cells can be detected in the internal or cavity side margins.
• Unlike CDP, the Margin probe and Mass pen are not calibrated and clinically examined for Lymph node and mass modes.
• As you can see in the last table, statistical analysis on 8000 samples showed 93% sensitivity and 91% specificity for CDP.
• CDP is a fast-response, handheld, portable, wireless, and user-friendly device that makes it a very helpful surgeon assistant.

 

The below Table provides some information about these four types of margin detection probes. The surgeon can select each of them based on their properties, performance, and application.

Technology	Tested Margin numbers/patients	Human in vivo/In vitro tests	The type of cancer tested	Declared Sensitivity /specificity	Diagnosis declaration time	The cost of the test	The cost of the device
Mass Spec Pen [1], [2]	253  patients	In vitro and in vivo on the tumor side margins	healthy and diseased thyroid, parathyroid, lymph node, breast, pancreatic, and bile duct tissues	96%-96%	10 sec.	100$	150,000$
Margin probe [3]	365 measurement sites	In vitro on the tumor side margins	Breast	67% - 60%	1 to 5 sec.	995$	50,000$
Confocal Laser Endomicroscopy (CLE) [4]	709 patients	Used by endoscopy channels to get the point and image	patients with Gastrointestinal and Pancreatobiliary diseases	89%-75%	Real-time	Not Found	Not Found
CDP	8000 human in-vivo clinical breast samples from more than 600 patients	In vitro and in vivo on the cavity side margins	Breast	93% - 91%	15 sec.	Each head probe 20$ (100$ for each patient)	80,000 $

[1]   J. Zhang et al., “Nondestructive tissue analysis for ex vivo and in vivo cancer diagnosis using a handheld mass spectrometry system,” Sci. Transl. Med., vol, 9, no. 406, p. eaan3968, 2017. [2]   J. Zhang et al., “Direct molecular analysis of in vivo and freshly excised tissues in human surgeries with the MasSpec Pen technology,” medRxiv, 2020. [3]   LeeVan, Elyse, Be Thi Ho, Sadie Seto, and Jeannie Shen. "Use of MarginProbe as an adjunct to the standard operating procedure does not significantly reduce re-excision rates in breast-conserving surgery." Breast Cancer Research and Treatment 183 (2020): 145-151. [4]  Pilonis ND, Januszewicz W, di Pietro M. Confocal laser endomicroscopy in gastrointestinal endoscopy: technical aspects and clinical applications. Transl Gastroenterol Hepatol. 2022 Jan 25;7:7.   Apart from the differences in Margin mode, CDP is the only one which can be used in the detection of lymph node involvement in the absence of a frozen section and for non-sentinel lymph nodes based on Electrical Impedance Spectroscopy.    

  First of all, it should be noted that CDP is not used for breast cancer detection. The system’s function and role is to find cancerous cells remaining in the cavity side margins. It means it can be used for breast cancer patients (or patients with preneoplastic cells in the CNB sample, such as ADH) who are diagnosed with CNB in preclinical evaluations. Invasive cancer cells of the tumor margin can escape from the tumor edges and make clustered scattered tumoral cells or satellite lesions in the peripheral tissues. These clusters can’t be easily detected by the surgeon intraoperatively. On the other hand, they are not being evaluated by any conventional pathological method. As you may know, ROS release is dominant in avascular stages (marginal cells) of cancerous tissue growth (with Hypoxia Glycolysis as their most abundant metabolism), while core cells of the tumor (vascular stage) go through acidosis. So, ROS level may be a distinctive indicator of cancerous cell presence in the margin. We have examined CDP in several types of tumor margins such as inflammatory breast lesions, scars, necrotic breast tumors, etc. and we found that ROS level detection is a completely distinctive parameter to classify all breast tumor margins into normal and cancerous lesions.