C4 IMAGING, LLC — Department of Health and Human Services SBIR Phase II: 102

Description

DESCRIPTION provided by applicant Brachytherapy radioactive seed implantation is an option for curative treatment chosen by up to of the men who develop prostate cancer in the United States each year Brachytherapy can produce excellent treatment outcomes but those outcomes vary depending on the quality of the treatment delivered which in turn depends on the positioning of the seeds C Imaging has successfully demonstrated and received FDA k clearance for an MRI Marker based approach to radioactive seed localization It addresses the need to improve treatment assessment dosimetry for men who undergo prostate brachytherapy through better anatomical delineation An enhanced MRI CT Marker will allow clinicians to incorporate both MRIandapos s optimal anatomical imaging and CTandapos s device identification to further improve treatment planning and assessment The overall goal of this proposal is to develop and implement an enhanced multi modality MRI CT marker by modifying the previous FDA approved C MRI Marker Improvements in device fabrication could be achieved if the current liquid fill of each MRI Marker were replaced by porous ceramic insert containing the positive signal MRI C solution Prototyping has identified that a highly porous ceramic zirconium core could address this and would add CT clinical imaging capabilities to the device The MRI CT Markers will undergo ISO biocompatibility testing before being validated in post production phantom based MR and CT functional assessment of production intent finished devices Fully validated devices will then be prepared for clinical use through a full assembly cycle that includes gamma and ethylene oxide sterilization and assessed for radioactive seed localization in a canine tumor model The data generated will be used to support FDA k approval C Imaging has demonstrated success in this area of research and is qualified to perform the work outlined in this proposal The team is active in developing MRI technology based on a positive signal MRI solution have experience in medical device development and fabrication and have expertise in the clinical use and marketing of medical devices used in prostate cancer PUBLIC HEALTH RELEVANCE C Imaging has successfully demonstrated and received FDA approval for an MRI Marker indicated for radioactive seed localization in prostate cancer treatment The overall goal of this SBIR proposal is improve device fabrication through the replacement of the current liquid fill of each MRI Marker with a porous ceramic zirconium insert containing C solution this in turn would add CT clinical imaging capabilities to the device The new MRI CT Marker will be validated and optimized in clinical phantoms and a canine tumor model with data generated being used to support FDA k approval