BIVISTA: multi-modality imaging for improving surgical intervention

Major cancers such as pancreatic and breast cancer (worldwide incidence of over 277,000 and 1,383,000 respectively) rely on surgical intervention. The challenge is to reduce the mortality rate for these and other types of cancer through interventional imaging techniques that can assist clinicians and surgeons at the time of operation. Clinical diagnosis forms the basis for improved patient management and we propose that high quality imaging at the point of care will contribute to better diagnosis and treatment outcomes for patients.

Gamma cameras are used routinely in many areas of medicine to image different tissue types and processes using radioactive 'tracer' compounds injected into the patient. The resulting images are of great value to the clinician in the staging and treatment of a variety of conditions. The combination of multi-spectral imaging, inherent in the BIVISTA system, will improve diagnosis and hence treatment management in a wide variety of cancers and other diseases. A patent application has been filed on the BIVISTA concept.

The advantages of the BIVISTA versus larger-field gamma cameras include:

Uniquely combines gamma and optical imaging

Much higher resolution which allows imaging of smaller areas of tissue or the study of other processes such as lymph drainage

Compact and mobile device offering real time imaging that can be used in a variety of environments, for example at the bedside and in the operating theatre.

Multi-modality imaging: simultaneous optical and gamma ray and the ability to map fluorescence markers; an emerging technology in surgical practice.

High spatial resolution information of 3D distribution of activity within the patient

BIVISTA will deliver significant healthcare benefits to a range of patients.

Breast cancer is the second leading cause of cancer deaths in women today (after lung cancer) and the most common cancer among women. Breast cancer incidence has recently been reported to be increasing with an estimated 300,000 - 400,000 deaths per year worldwide (A.K. Arun, Frost and Sullivan 2006). Worldwide pancreatic cancer deaths amount to 266,000 per annum. These cancers critically depend upon surgical intervention. Intra-operative imaging has the potential to improve surgical outcome.

Over the last 10 years a number of applications have been developed based on gamma probe technologies. These applications include tumour detection, infection imaging and orthopaedic care. The concept of sentinel node biopsy has been applied to assist in the identification of patients for complete lymph node dissection (S. Salvador et al, J. Inst. 2 (2007) P07003). Sentinel node imaging via lymphoscintigraphy (H.S. Koops et.al, Radiotherapy and Oncology 51 (1999) 1-7) has become an important technique for determining the stage of cancer and, in particular, whether the disease has spread from the primary tumour to the lymphatic system. The use of sentinel node biopsy may avoid the need for inguinal lymphadectomy in patients with negative nodes. Many UK hospitals are in the process of assessing the sensitivity of intra-operative sentinel node mapping in a range of cancers. This procedure is becoming standard and is carried out over 2 million times annually. For this procedure to be successful it is necessary to identify the sentinel node pre-operatively. Our technology offers the potential for a low-cost, high-performance method of imaging the sentinel node. Other applications include the high resolution imaging of small organs such as the thyroid and skeletal joints (knees, ankles, elbows) and in gastroenterology.

In addition, BIVISTA, will be able to image hybrid fluorescent-radioactive tracers: fluorescence labelled compounds eg. ICG (indocyanine green) that also have radioisotope labelling, eg ICG- 99mTc nanocolloid (Brouwer et al J Nucl Med. 53 (2012) 1034-40). This emerging technology in SLNB, overcomes one of the disadvantages of the blue dyes currently used which are known to leave long term skin colouration. In addition emerging fluoro probes can be tumour or lymph specific, unlike the blue dyes. Combining these new innovations with the ability to estimate the depth and distribution of the markers in relation to patient anatomy will greatly enhance the information available to clinicians and surgeons and lead to better diagnosis and treatment pathways.

BIVISTA will bring economic benefits to healthcare by reduced costs of the imaging procedures, improved patient outcomes and reduced follow-up treatment. Commercially the system will be highly competitive with existing commercial systems but will have an edge due to its unique (and patented) properties. Both Gamma Technologies and Xstrahl will benefit commercially from the new system when it reaches the market place.

Academic beneficiaries will include researchers working in the radiation detection field, especially those in nuclear medicine, who will obtain new understanding of portable compound multi-spectral imaging in the medical arena, along with those groups working in other areas where imaging is important e.g. veterinary and environmental monitoring.