SBIR-STTR Award

The purpose of this Phase I project is to develop a 3-micron stabilized microbubble for tumor detection when used in conjunction with ultrasound. Gelatin microbubbles have been shown to adhere to abnormal vessel walls. Because bubbles act as ultrasonic reflectors, small quantities of microbubbles can be visualized with clinical ultrasound, and it is hoped that they will be effective in detecting small tumors Such bubbles act as sitespecific tumor markers when they adhere to tumor vessel walls for up to 15 minutes, but microbubbles entering normal tissue dissolve and clear in minutes. In order to provide the clinician with some control over the microbubbles, a biocompatible iron oxide, which is capable of being displaced by a magnet, is added to the bubble wall. Thus, using ultrasound, the clinician can observe the bubble agents while under magnetic guidance in order to concentrate them in the target area. The primary goal of the proposed Phase I effort is to develop a bubble generator capable of producing 3-micron gelatin-encapsulated microbubbles. Phase II activities will be aimed at quantification and optimization of the technique in vivo with implanted and spontaneous tumorsAwardee's statement of the potential commercial applications of the research:It is estimated that 1 million people in the United States will develop cancer this year. Survival is largely dependent upon early diagnosis and treatment. The proposed technique is oriented to identifying early tumors. If this agent proves safe and efficacious, a substantial business opportunity existsNational Cancer Institute (NCI)

Gelatin Encapsulated Microbubbles (GEM) adhere to tumor vessel walls for periods of time up to 10 minutes. Because bubbles are highly echogenic to ultrasound, they act as ultrasonic reflectors and identify the vasculature of tumors. Normal vessels clear bubbles quickly. Thus this time lag between the two permits separation and localization of tumors. It is hoped that they can be used to identify small tumors. Phase I program developed a 3 micron GEM microbubble capable of clearing the lungs to enter the systemic circulation. In order to increase the number of bubbles entering a general area, magnetite, a magnetic iron oxide, has been added to the inner wall. Thus the clinician can steer particles entering general area and increase the local population and echogenicity. The primary goal of Phase II studies is to demonstrate efficacy of the concept in vivo. The agent will be tested on tumor models and on spontaneous tumors in dogs and cats. Following optimization of particles methodology will be developed to assess various types of cancer using a mouse model. The intent of the technology is to detect small tumors when the possibility of cure is greatest.Awardee's statement of the potential commercial applications of the research:The American Cancer Society estimates that 1 million people in the United States will contract cancer this year. Survival is largely dependent upon early diagnosis and treatment. The technology is oriented at identifying early tumors. If our agent is demonstrated efficacious and safe, a substantial business opportunity would exist.National Cancer Institute (NCI)