Early disease detection through percutaneous needle biopsies is considered the gold standard for cancer diagnoses and thus for obtaining good health outcomes. This project seeks to ameliorate health disparities by making it possible for general practitioners and other health professionals to perform image-guided needle biopsies in their own office or clinic rather than sending patients with suspect lesions to distant centers. Th key enabling technology is an ultrasound-based guidance system designed to provide intuitive and reliable in-situ guidance that can be used by interventionalists with minimal training, allowing doctors to perform needle biopsies on patients in their own clinic or office. The project consists of three aims.
The first aim will develop and evaluate an easy-to-use guidance system for targeted needle biopsy by focusing on the development of the guidance platform itself, including device construction, internal calibration, interfaces to the ultrasound system, and the development of several guidance modes.
The second aim will extend guidance system with registration between pre-operative CT and ultrasound foriImage-guided interventions, by providing new algorithms for ultrasound- and surface- to CT registration, making it possible for expert annotations of critical structures to be transferred to the guidance system directly.
The third aim will evaluate the system on phantom models and in a pilot animal study by practitioners of varying skill and training levels, and comparing it to state-of-the-art guidance systems.
The third aim i ncludes the creation of a health disparity advisory board to guide the further development of the device for deployment to reduce health disparities in rural and underserved populations.

Public Health Relevance

Application title: A Low-Cost, Portable Guidance System for Needle Biopsy Funding Opportunity Announcement number: RFA-EB-12-001 The development of a low-cost, portable guidance system for needle biopsy will reduce health disparities by giving primary care personnel the ability to do diagnostic testing for cancer and liver disease staging in the primary care office or mobile unit. By producing a guidance system that is simple to use for less experienced medical personnel, and by making it cheap enough for small clinics to be able to afford, this technology reduces diagnostic health disparities created by the geographic, ethnic or economic differences which can limit access to care.

Agency
National Institute of Health (NIH)
Institute
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43EB015377-01A1
Application #
8472296
Study Section
Special Emphasis Panel (ZEB1-OSR-B (J1))
Program Officer
Krosnick, Steven
Project Start
2013-08-01
Project End
2015-07-31
Budget Start
2013-08-01
Budget End
2014-07-31
Support Year
1
Fiscal Year
2013
Total Cost
$199,049
Indirect Cost
Name
Clear Guide Medical, LLC
Department
Type
DUNS #
965399905
City
Baltimore
State
MD
Country
United States
Zip Code