HistoScanning™ is a tissue differentiation, visualization and quantification tool for diagnosis support. The technology can be adapted and trained to differentiate tissues in organs accessible by ultrasound. An application is being developed to address the clinical challenges associated with the differentiation and localization of thyroid cancer. Thyroid HistoScanning™ is currently in its proof of concept phase.

Thyroid Cancer Background

• Thyroid cancer is the most common endocrine-related cancer. However, it is relatively rare compared to other cancers (the estimated lifetime risk of thyroid cancer in the USA is 1 in 127)¹.
• Thyroid cancer is one of the few cancers that has increased in incidence rates over the past several years². Each year approximately 28,000 new cases are diagnosed in Europe vs. 20,000 new cases diagnosed in the United States³.
• Thyroid cancer is more common in people older than 40 years of age and its aggressiveness increases significantly in older patients^1,4.
• Females are more likely to have thyroid cancer at a ratio of three to one⁴.
• Most patients, especially in the early stages of thyroid cancer, do not experience symptoms. However, as the cancer develops, symptoms may include a lump (nodule), swollen lymph nodes, difficulty swallowing, and pain.
• Thyroid nodules have a high incidence in the general population. By autopsy series, there is up to a 50% incidence of single or multiple nodules. In unselected populations, there is up to a 4% incidence by palpation. However the majority of thyroid nodules (9 out of 10) are benign⁵.

Thyroid cancer is one of the most curable of all cancers. In fact, if the disease is detected early and treated appropriately, it can be managed effectively in most patients.

Because the vast majority of thyroid nodules are benign, it is clinically challenging to determine which ones are cancerous and aggressively invasive. The definitive step in diagnosing a suspicious nodule is often a fine needle aspiration (FNA) guided or not by conventional ultrasound. This test plays a critical role in the histologic confirmation of suspected thyroid cancer. It usually, but not always, tells the doctor if a nodule is benign or malignant. Ultrasound imaging, by itself, accurately defines the features (eg. solid or cystic) and the size of the nodule. However, it is considered ineffective for the identification of small thyroid lesions and it is highly dependent upon the examiner. Other available tests may include selected blood tests (eg. serum TSH, thyroglobulin, and calcitonin levels) and specific imaging techniques (eg. radioiodine whole body scan, CT scan, and MRI). These methods may help physicians assess the functioning nature of a nodule and aid the diagnosis of thyroid cancer.

Diagnosed patients have different therapy options available including surgery, radioactive iodine and radiation therapy, depending on the stage and type of thyroid cancer. Surgery in general plays the central role, with the removal of the cancer being key. The most popular surgical procedure is a total thyroidectomy or a near total thyroidectomy. However today, a removal of a single lobe of the thyroid gland is only considered if the tumor has a good prognosis and is macroscopically located in one lobe and if neck lymph nodes are negative. When total thyroidectolmy is performed, patients are treated with thyroid hormone replacement therapy. Most thyroid cancers that are treated have very good prognosis, however, cancer recurrence may occur in up to 30% of the patients⁶. Most importantly, recurrences can occur even decades after the initial diagnosis. Therefore it is necessary that patients get regular follow-up examinations and tests to detect whether the cancer has re-emerged, which should be continued throughout the patient's lifetime. Ultrasound-based diagnostic aids provide a non-invasive alternative to actively monitor disease recurrence.