Novel Bowel Contrast Agent for Dual Energy CT

DESCRIPTIONprovided by applicantOur long term goal is to revolutionize the effectiveness of computed tomographyCTimaging for millions of Americans across a broad range of gastrointestinal diseaseBowel and intravenous contrast agents are critical for CT imaging of abdominal diseaseUnfortunatelynone of the current clinical contrast agents are visibly different from the others at imagingeven on modern dual energy CTDECTscannersbecause all agents are based on iodine or barium which attenuate X rays similarly across different X ray spectraThis limitation of CT leads to ambiguous images that cost over $ B in medical errors annually in the USAWe present dramatic preclinical in vivo data showing that novel oral silicone agents can be delivered concurrently with yet be easily differentiated from current iodinated intravenous agents to give simultaneoushigh resolutionperfectly co registered CT images of the bowel and vasculature in a single pass of a DECT scannerSuch double contrast enhanced DECT scans provide richly detailed interrogation of anatomy at lower radiation dose than a conventional CT scaneliminate protocol errorsaccelerate diagnosesand will dramatically reduce health care costsOur agent is disruptive because silicone has not been previously described as an X ray attenuating material for CTOur development pathway is straightforward and ideal for the SBIR Fast Track program because our agent shows dramatic efficacyhigh safetyand does not alter the normal workflow of CT imagingOur prototype agent already shows favorable preclinical safety results over that of available barium agentsDECT scanners are increasingly clinically availableOur overall hypothesis is that a novel silicon based material is suitable for use as the first DECT bowel contrast agent for differentiation from other agentsOur Specific Aims are toPerform stepwise preclinical toxicity tests on three candidate variants of our lead agent to select a final formulation for developmentObtain scaled up clinical Good Manufacturing Practice formulation and Good Laboratory Practice toxicity tests in rat and dog to achieve FDA IND approvalDemonstrate that our bowel contrast material is safe healthy volunteers in PhaseClinical trialsConfirm that our bowel contrast material is readily differentiated from iodinated agents by DECT in a PhaseClinical trialAimandquot SBIR Phase IandquotAimsandquot SBIR Phase IIandquotof the Fast Track programAt the conclusion of this proposalwe will have shown safety of the first silicone bowel DECT contrast agent in healthy human volunteers and shown disruptive imaging efficacy for double contrast enhanced DECTThese key data will enable subsequent Clinical Phasetests of our DECT agent in appropriate patients with abdominal disease to catalyze a frame shift in CT imagingincreased speedaccuracyand confidence of CT imaging diagnoses for everyday abdominal scenarios at reduced cost to the healthcare system and lower radiation dose PUBLIC HEALTH RELEVANCEThough contrast agents are critical to medical CT imagingover $billion in medical errors occur annually from our inability to differentiate between bowel and intravascular contrast agents at imagingWe will develop the first safe clinical bowel contrast agent that is visibly distinct from all current intravascular agents at dual energy CTThs safe and efficacious clinical bowel contrast agent will allow double contrast enhanced dual energy CT to give richly detailed co registered images of complex abdominal anatomy for millions of Americans at a low radiation dose and major cost savings to the healthcare system