?The long-term goal of this Phase I STTR project is to develop a commercially viable ultrasound contrast reagent (UCR) that will allow the noninvasive identification of newly forming abdominal adhesions after surgery. Successful implementation would have significant impact because we would remove the impediment to clinical testing of anti-adhesion therapies, and at the same time would improve patient post-surgical monitoring in general. Although surgical adhesions have "fallen under the radar" when it comes to public perception, their heavy impact on the United States health care system is undeniable. Roughly 7 million abdominal surgical procedures of all types are carried out annually, and almost 100% of these patients will develop adhesions. While most are asymptomatic, a significant number can lead to serious and even life- threatening complications. This investigation will build on preliminary findings using the same targeting approach to adhesions that has already proven useful in fluorescent contrast reagents. To successfully bring adhesion imaging into a clinically relevant format the aims therefore include first synthesis and characterization of a polymer-stabilized, adhesion-targeted, ultrasound microbubble, followed by testing refinements in a relevant cell culture model. The successful targeted UCR formulations will then be examined in a limited number of animals to determine adhesion recognition and ultimately detection by non-invasive ultrasound interrogation. While the Phase I studies described here will be conducted using a well-characterized rat surgical adhesion model, our long-term aim is to develop UCRs that can image fibrinous "protoadhesions" in surgical patients. This product would not only allow the early alleviation of potentially problematic adhesions, but also overcome the main barrier to the testing and development of adhesion prevention therapies. Due to the huge magnitude of the problem, even a 50% reduction in post-surgical adhesions could save over $2.5 billion yearly in healthcare costs.
Public Health Relevance Statement: Public Health Relevance: This project seeks to develop a commercially viable ultrasound contrast reagent (UCR) that will allow the noninvasive identification of newly forming abdominal adhesions (deposits of fibrous scar tissue) after surgery. Successful implementation would have significant impact because we would remove the impediment to clinical testing of anti-adhesion therapies, and at the same time would improve patient post-surgical monitoring in general.
Project Terms: Abdomen; Abdominal Surgical Procedures; Acoustics; Adhesions; Animal Model; Animals; base; Biocompatible Materials; Cell Culture Techniques; Cicatrix; Clinic; Clinical; clinically relevant; Contrast Media; Deposition; Development; Diagnostic; Early Intervention; Engineering; Evaluation; falls; Fibrin; Formulation; Future; Goals; Greater sac of peritoneum; Health Care Costs; Healthcare Systems; Hospitals; Human; Image; imaging modality; imaging system; Imaging technology; improved; In Vitro; in vivo imaging; Investigation; Laboratory Animals; Lead; Life; Liposomes; Medical; Membrane; Microbubbles; Modeling; Monitor; Non-Invasive Cancer Detection; novel; operation; Operative Surgical Procedures; Patients; Peptides; Perception; Phase; phase 1 study; Polymers; Prevention; Prevention therapy; Procedures; public health relevance; Rattus; Reagent; Research; research clinical testing; Safety; Science; Scientist; Second Look Surgery; Small Business Technology Transfer Research; small molecule; Specificity; success; Surgical Models; Synthesis Chemistry; Technology; Testing; Time; Tissues; Treatment Cost; Ultrasonography; United States
