Dedicated breast computed tomography (truly 3D breast imaging, known as ‘breast CT’ or 'mammotomography'), developed by Zumatek, Inc., uses the latest innovations in digital flat-panel detector technology and x-ray beam spectral filtration, combined with a sensitively designed patient support, and has the following advantages over conventional mammography and tomosynthesis (a pseudo-3D technology):
- As opposed to conventional mammography, there is no need for breast compression (‘touchless’), which makes dedicated breast CT considerably more easily tolerated by patients.
- This technology allows for 3D reconstruction, and therefore provides additional information to the radiologist. Similar in principle to existing CT, which has already been established as an important complement to conventional radiography and has found many applications in medical imaging, dedicated breast CT can complement mammography diagnostically, and has the potential to replace it altogether. While future clinical trials are necessary to determine the sensitivity and specificity of dedicated breast CT for cancerous lesion detection, time and again CT imaging has out performed its planar radiographic cousin(s) in organ or disease specific imaging trials.
- Based on preliminary clinical observations with the Zumatek scanner, dedicated breast CT has excellent performance in dense breasts, and in the presence of implants.
- Zumatek’s CT technology can acquire reliable data at a lower radiation dose than that delivered through contemporary X-ray mammography. This is accomplished through the use of proprietary filtering techniques and may be a significant advantage when screening younger women (since the breast is both dense and highly radiosensitive). For instance, dedicated breast CT may be suitable for patients with a predisposition to develop breast cancer, such as in the presence of BRCA1 or BRCA2 gene mutations.
- When compared to conventional mammography, dedicated breast CT can also image small breasts (including men), the nearby chest wall, and even the axillary lymph nodes. This could potentially allow for detection of metastasis in addition to primary cancerous lesions.
Zumatek has already developed advanced dedicated breast CT prototypes. An NIH-funded SBIR Phase II project has helped Zumatek develop its technology further, perform a pilot clinical trial with 27 patients, and bring the technology to the stage where the company is poised to seek FDA approval. Financing and/or strategic partnering will further support the company through the FDA approval process and subsequent commercialization.