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Minimally-Invasive Catheter-based Ultrasound for Precision Tumor Ablation in Lung

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43CA236065-01A1
Agency Tracking Number: R43CA236065
Amount: $270,494.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 102
Solicitation Number: PA18-574
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-04-01
Award End Date (Contract End Date): 2020-03-31
Small Business Information
Savoy, IL 61874-9510
United States
DUNS: 606222896
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (217) 239-0900
Business Contact
Phone: (217) 239-0900
Research Institution

Project Summary Lung and bronchial cancers remain the leading cause of cancer related deaths in both men and women worldwideCT guided percutaneous RF and MW thermal ablation has been shown to provide local control and survival benefit for treatment of small lung tumorsbut with limitations imposed upon treatable or accessible regionslack of spatial and dynamic control of ablative therapy to effectively destroy larger tumorsand frequent complications such as pneumothoraxThere remains a substantial and unmet clinical need for a minimally invasive technology for ablation of pulmonary tumors which can produce more consistent and larger conformal ablation zonesaccess more tumor sites in a less invasive fashionwhile under real time image guidanceSpecificallytumor in the lung surrounded by air filled lung parenchyma is thermally insulated and will require less energy for a given volume of ablationCatheter based ultrasoundCBUSis a novel thermal therapy technology with potential for dynamic and conformal spatial control of ablationhas effective energy penetrationand is delivered under CT fluoro image guidance for real time treatment targeting and deliveryIn this proposal we plan to develop and establish the feasibility of catheter based ultrasound technologies specific for lung tumor ablation using CT fluoro guidanceBuilding upon the expertise of our groupwe pose that catheter based ultrasound devices can be developed to provide a technique for endobronchial or intraluminal treatment of lung tumors adjacent to central and peripheral airwaysrespectivelyas well as small interstitial devices for a percutaneous approachFavorable energy penetration across the bronchial wall and preferential absorption and reflection of ultrasound energy at the tumor margin preferentially localizes therapy within tumor and nearby surrounding marginwith larger volume heating possibleThe objectives of this project are toperform proof of concept development and determine feasibility of high intensity endobronchial and percutaneous ultrasound for image guided thermal treatment of lung tumors and also minimize percutaneous device size while retaining volume ablationperformD anatomical biothermal simulation studies toward applicator design and development of therapy delivery strategiesimplement new devices and demonstrate targeting within lung tumor alone for guidance of catheter based ultrasonic ablationand perform in situ evaluations of the endobronchial and percutaneous ultrasound catheters under MDCT image guidance in a porcine modelapplying delivery strategies and techniques as developed hereinWe anticipate that given a positive outcome of this exploratory studythe devices and imaging techniques can be further developed and evaluated more extensively in animal trials and eventual human pilot studiesSignificant potential advantages of this technology include less invasive endobronchial and intraluminal access to more tumor sitesprecision ablation of larger volumesreal time control and treatment verificationthus improving responsereducing complicationsand benefiting a greater number of patients Project Narrative Lung and bronchial cancers remain the leading cause of cancer related deaths in both men and women worldwideThe standard treatment for early stage diseaseand select metastatic tumorsis surgical resectionFor patients with unresectable tumors or are poor surgical candidatesalternative treatment options include radiotherapychemotherapyand image guided ablation with radio frequencyRFmicrowaveMWlaser or cryotherapyLack of volumetric and directional spatial distribution control of heatingmost notably with RFcan limit the dimensions of tumors that can be treated effectivelyPercutaneous ablation of tumors near the central upper lung and airways is often contraindicated due to the presence of critical structures within the needle trajectoryWe propose exploratory studies to establish the feasibility of using novel minimally invasive catheter based therapeutic ultrasound devices with directional and conformal energy pattern capability to provide controlled thermal ablation in lung tumors under CT fluoroscopic guidanceThis approach can provide a precise and less invasive technique for ablation of lung tumors compared to existing methodsthus improving clinical response and benefiting a greater number of patients

* Information listed above is at the time of submission. *

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