This invention relates to a novel radiotracer that has proven effective for use in SLN scintigraphy during the surgical detection and treatment of breast cancer

Summary of Invention:

This invention concerns methods for the preparation and use of a novel radiolabelled colloid that has exhibited promise for commercial development as an imaging agent with broad imaging applications. ^99mTc Cysteine-Rhenium Colloid is smaller than existing commercial colloids (10–12 nm), is of high radiochemical purity and stability, is of neutral pH, and requires no filtration. Based on the properties, the unnecessary exposure of technicians to radiation and product loss during preparation is minimized, while superior resolution and patient comfort has been achieved in animal studies and clinical investigations performed to date. 

^99mTc Cysteine-Rhenium Colloid has been shown to exhibit a high degree of entrapment in the primary nodes of rabbits during sentinel lymph node (SLN) scintigraphy and in preliminary investigations of breast cancer in humans. These findings have been summarized in a number of recent peer reviewed scientific publications and poster presentations. ^99mTc Cysteine-Rhenium Colloid has been extensively formulated by the hospital radio-pharmacy for clinical use as an imaging agent in lung inhalation and ventilation studies. Other studies suggest comparatively higher liver uptake and femur to blood ratios following intravenous (iv) administration to mice. No adverse effects have been reported following administration of ^99mTc Cysteine-Rhenium Colloid to animals and greater than 4000 patients within the hospital clinic over the last 4 years. Administrations have been representative of all proposed routes of delivery of the colloid (60% aerosol, 22% iv, 12% oral, 8% sc or id). Based on the data available, ^99mTc Cysteine-Rhenium Colloid has been demonstrated effective as a radiotracer for SLN scintigraphy and holds promise for further development in bone marrow, liver/spleen RES scanning, and lung aerosol applications.  

Market Opportunity:

Radiotracers have been broadly used in nuclear medicine to assist with the visualization of organs, tumours, blood vessels and other structures, and for the detection, diagnosis, and treatment of disease (e.g., cancer, cardiovascular). More than 36 million imaging exams are performed in the United States each year. The value of the market for imaging agents within the United States is estimated to be $1.6 billion with some of the most broadly adopted agents achieving $1 billion in worldwide sales. ^99mTc Cysteine-Rhenium Colloid is expected to compete successfully in the market that exists for a safer and more effective colloid in SLN scintigraphy, bone marrow, liver/spleen RES scanning, and ventilation lung applications.

Patent and patent applications exist in the United States and Canada.

The technology is available for licensing and/or collaborative research and development with an industry partner.