DeHCA Light & Sound (DeHCA L&S) is an innovative medical device aimed to detect breast tumors’ preparatory stages before tumors are settled and visible, independently of breast density and size.
DeHCA L&S is based upon optical and ultrasound technologies, not ionizing, painless and riskless. It makes available to physicians functional and morphological information.
The DeHCA L&S looks for the tumor-feeding vascular network rather than the tumor itself, because the vascular network arises early in the disease, and results in vascular changes affecting vessels beyond the tumor itself, thus being earlier identifiable.
DeHCA L&S evaluates the variation of concentration of deoxy-hemoglobin within the breast tissues, whose abnormal values can be associated to the insurgence of tumor-feeding vascular networks (neo-angiogenesis).
With DeHCA L&S physicians perform an initial optical examination with the objective to identify and locate areas of likely lesions. If any suspect areas are identified, physicians proceed to an ultrasound examination to exactly locate and qualify the lesion and eventually support a guided biopsy.
DeHCA L&S is made of the following main subsystems:
Breast Holder: the reliability of the combined functional – morphological examination depends on the correct positioning and immobilization of breast during the two exams. The Breast Holder is based upon an innovative silicon Pressure Applicator patented by Novaura, where a simple pressure/vacuum mechanism makes the external ambient pressure to be superior to the pressure inside the breast holder. In this way the silicon membrane collapses on the breast and, perfectly adhering to it, provokes its immobilization on a properly shaped platform. The mild pressure exercised by the applicator stops the capillary blood flow for a short while allowing to evaluate the absorption of oxygen.
Optical Information Acquisition: 49 LED’s are placed below the platform to illuminate the breast with bottom-up 640nm red light. 640nm is the wavelength at which healthy and pathologic tissues show the maximum difference in absorption of oxygen and, consequently, in transparency.
A CCD camera situated above the scan area acquires images of the breast vessels network, discriminating normal and pathologic areas according to their red light absorption. Acquired images are post-processed and displayed in form of chromatic map.
Ultrasound Information Acquisition: an ultrasound transducer, hosted below the CCD camera, is used to exactly locate the lesion identified by the optical scan.
Presentation Software: ultrasound and functional images can be directly compared.
DeHCA L&S overcomes the limitations of the present Gold Standard being effective on dense breasts and small breasts.
The combined optical and ultrasound examination ensures:
- Cost-effectiveness: one device, one exam and one site;
- Safe diagnosis: comprehensive diagnosis based upon the two examination findings.