A significant number (~30-50%) of liver cancers have no curative treatments due to their proximity to critical anatomy. Minimally invasive thermal ablation is a promising treatment for these untreatable solid tumors. If delivered precisely, ablations offer the treatment efficacy of traditional surgery with lower patient risk, clinician time, and overall cost. Existing ablation technology, however, does not offer the necessary precision. Ablation tools do not provide feedback on (1) whether or not the probe has been accurately placed within the tumor, (2) if the tumor has been completely destroyed, or (3) if surrounding healthy tissue has been left intact. Because of this lack of precision and feedback, ablation cannot currently be used to treat tumors near critical anatomy. A proposed solution to these currently untreatable cancers is an ultraprecise ablation needle, embedded with high-resolution ultrasound sensors at its tip. These sensors will provide multiple
Benefits: aiding the clinician in placing the device correctly by imaging the tumor relative to the needle, delivering the treatment energy to a precise location through focusing, and providing real-time monitoring of the procedure by detecting the thermal changes in tissue-all without the need for a large imaging system. This innovation will allow surgeons to complete an ablation with the required precision to treat even the most difficult-to-reach cancers. This Phase 1 SBIR proposal will demonstrate the capabilities of small-scale ultrasound transducers to precisely control ablations near critical anatomical structures (e.g., arteries) in an in vivo porcine model through three specific aims: (1) optimization of previously developed ultrasound-based ablation zone estimation in ex vivo liver tissue using deep learning and physics-based simulations, (2) ablation zone estimation in an in vivo porcine liver model, and (3) demonstration of in vivo closed-loop ablation zone control near critical anatomy (artery in liver). Completion of this phase will demonstrate the key technology in a pilot animal study, where Phase 2 work would address critical development milestones to commercialization for an anticipated Class 2 device (approval via de nova regulatory pathway).
Public Health Relevance Statement: Project Narrative Liver cancer is a deadly disease, with 43,000 new diagnoses every year in the United States and a five year survival rate of only 18% (SEER database, 2020). Although we can detect liver cancer at an early stage, more than 35% of these patients are ineligible for effective treatments such as surgery or traditional ablation due to the tumor's proximity to critical anatomy. The proposed device will expand the use of ablation to allow for early-stage precise interventions, not only for currently untreatable liver tumors (affecting more than 6,600 in the United States annually), but also for a broad range of cancers such as those in the kidney, lung, and breast-regardless of proximity to critical structures-and could also improve neurological and cardiac ablation treatments for conditions such as epilepsy and atrial fibrillation in both adult and pediatric populations (affecting more than 8 million patients in the United States annually).
Project Terms: Acoustic; Acoustics; 21+ years old; Adult Human; adulthood; Adult; Affect; Algorithms; Anatomic Sites; Anatomic structures; Anatomy; Animals; Arteries; Atrial Fibrillation; Auricular Fibrillation; Breast; Malignant Neoplasms; Cancers; Malignant Tumor; malignancy; neoplasm/cancer; Cryosurgery; Cryoablation; Disease; Disorder; Epilepsy; Epileptic Seizures; Epileptics; Seizure Disorder; epilepsia; epileptogenic; Feedback; Goals; Incidence; Kidney; Kidney Urinary System; renal; Liver; hepatic body system; hepatic organ system; Liver neoplasms; Hepatic Neoplasms; hepatic neoplasia; hepatic neoplasm; hepatic tumor; liver tumor; Lung; Lung Respiratory System; pulmonary; Marketing; Methods; microwave electromagnetic radiation; Microwave Electromagnetic; Microwaves; microwave radiation; Needles; Patients; Perfusion; Physics; Pilot Projects; pilot study; Survival Rate; Family suidae; Pigs; Suidae; Swine; porcine; suid; Technology; Testing; Time; Tissues; Body Tissues; Transducers; United States; Work; Catheter Ablation; Cardiac ablation; image processing; sensor; Ultrasound transducer; Ultrasonic Transducer; improved; Procedures; Left; Site; Phase; Neurological; Neurologic; Training; pediatric; Childhood; Data Bases; data base; Databases; Solid Tumor; Solid Neoplasm; Shapes; tool; Malignant neoplasm of liver; Hepatic Cancer; liver cancer; liver malignancy; malignant liver tumor; Techniques; Location; Recurrent tumor; Recurrent Neoplasm; neoplasm recurrence; Operative Surgical Procedures; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; Ablation; Surgeon; Performance; Thermal Ablation Therapy; thermal ablation; thermal tumor ablation; Structure; simulation; Devices; Positioning Attribute; Position; Screening for Hepatocellular Cancer; early liver cancer detection; liver cancer detection; screening for liver cancer; Modeling; Property; Intervention; Intervention Strategies; interventional strategy; cancer therapy; Cancer Treatment; Malignant Neoplasm Therapy; Malignant Neoplasm Treatment; anti-cancer therapy; anticancer therapy; cancer-directed therapy; cancer diagnosis; Address; Data; Detection; Regulatory Pathway; Resolution; resolutions; in vivo; in vivo Model; Focused Ultrasound Therapy; Focused Ultrasound Ablation; Focused Ultrasound Treatment; High Power Focused Ultrasound; High-intensity focused ultrasound; Newly Diagnosed; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Development; developmental; cost; intervention efficacy; therapeutic efficacy; therapy efficacy; Treatment Efficacy; site targeted delivery; targeted delivery; oncologic imaging; oncology imaging; tumor imaging; cancer imaging; Population; innovate; innovative; innovation; commercialization; tumor; minimally invasive; effective treatment; effective therapy; Patient risk; imaging system; curative intervention; curative therapeutic; curative therapy; curative treatments; in vivo testing; in vivo evaluation; realtime monitoring; real time monitoring; deep learning; realtime image; real-time images; algorithm training; detection procedure; detection technique; detection method; pig model; piglet model; swine model; porcine model; ultrasound
