An integrated optical coherence tomography and tissue acquisition device for diagnosis of indeterminate biliary strictures

Information

  • Research Project
  • 9777889
  • ApplicationId
    9777889
  • Core Project Number
    R43CA239869
  • Full Project Number
    1R43CA239869-01
  • Serial Number
    239869
  • FOA Number
    PA-18-574
  • Sub Project Id
  • Project Start Date
    3/15/2019 - 5 years ago
  • Project End Date
    2/29/2020 - 4 years ago
  • Program Officer Name
    EVANS, GREGORY
  • Budget Start Date
    3/15/2019 - 5 years ago
  • Budget End Date
    2/29/2020 - 4 years ago
  • Fiscal Year
    2019
  • Support Year
    01
  • Suffix
  • Award Notice Date
    3/15/2019 - 5 years ago

An integrated optical coherence tomography and tissue acquisition device for diagnosis of indeterminate biliary strictures

ABSTRACT Bile duct strictures can lead to painful clinical symptoms and can be caused by a wide range of conditions from benign diseases to cholangiocarcinoma, a deadly cancer of the bile duct with 5-year survival rates as low as 2% for late stage disease. The management and prognosis of bile duct strictures varies significantly, so accurate diagnosis and differentiation between malignant and benign strictures is critical. Currently the most common way to differentiate a biliary stricture is to perform biopsy or brush cytology with the use of endoscopic retrograde cholangiopancreatography (ERCP). However, the diagnostic yield is low due to small tissue sampled with limited image guidance. Endoscopic optical coherence tomography (OCT) provides wide field imaging of the surface and subsurface tissue microstructure, and has been previously evaluated for use in the biliary system with promising results. The goal of this project is to develop and evaluate a single device to perform precise image guided biopsy within the biliary system. Here, we will combine OCT to visualize abnormalities over a wide field of view to provide high disease sensitivity, along with an integrated tissue acquisition tool for pathological confirmation of abnormalities to provide high specificity. In aim 1, we will develop a prototype miniaturized and flexible OCT probe with integrated tissue acquisition, enabling precise image guided biopsy. Aim 2 is to evaluate the feasibility of this tool in a simulated biliary model to acquire tissue samples under image guidance and verify the one-to-one co-registration.

IC Name
NATIONAL CANCER INSTITUTE
  • Activity
    R43
  • Administering IC
    CA
  • Application Type
    1
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    222020
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    394
  • Ed Inst. Type
  • Funding ICs
    NCI:222020\
  • Funding Mechanism
    SBIR-STTR RPGs
  • Study Section
    ZRG1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    NINEPOINT MEDICAL, INC.
  • Organization Department
  • Organization DUNS
    961880999
  • Organization City
    BEDFORD
  • Organization State
    MA
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    017301443
  • Organization District
    UNITED STATES