This Phase-II SBIR project is in response to PAR-01-102, """"""""Development of Novel Technologies for In Vivo Imaging."""""""" Expanding upon our Phase-I feasibility effort, we propose to construct and validate a complete workstation - the Virtual Navigator- for 3D MDCT-based planning and guidance of bronchoscopic biopsy. Lung cancer is the most common cause of cancer death in the western nations, with the current 5-year survival rate under 15%. Despite continued technological improvements, the lung-cancer mortality rate actually increased 11% between 1979 and 1997. The state-of-the-art procedure for diagnosing and staging lung cancer involves three-dimensional (3D) multi-detector computed-tomography (MDCT) scanning followed by bronchoscopic biopsy. Unfortunately, a high percentage of biopsy procedures are unsuccessful because of the: (1) lack of procedure-planning tools, (2) difficulty in seeing biopsy sites during bronchoscopy, and (3) wide range in physician skill level. The project is driven by the following hypothesis: A computer-based system, enabling 3D MDCT-based procedure planning and follow-on image-guided bronchoscopy, can improve current procedures for the staging, diagnosis, and treatment of lung cancer.
The specific aims are as follows.
Aim 1 : Devise automated methods for MDCT-based procedure planning and image-guided bronchoscopy, thereby enabling more effective biopsy planning and subsequent bronchoscopic biopsy.
Aim 2 : Prototype a workstation for the interactive planning and guidance of bronchoscopy, thereby providing the physician with a user-friendly system for image-guided bronchoscopy.
Aim 3 : Perform human studies to establish system functionality and to compare the system to standard practice.These studies, which focus on the bronchoscopic biopsy of suspect mediastinal lymph nodes and peripheral nodules, give a preliminary clinical evaluation and motivate later Phase-Ill and FDA 510K tests. Since the current techniques for diagnosing and staging lung cancer are unsatisfactory, it is critical that accurate tools become available for assessing lung cancer. Further, the impact of therapy and treatment remains largely unchanged over the last twenty years. The image-guided methods featured by the proposed system could make possible the accurate delivery of agents directly into the lung tumor nodule or into involved lymph nodes. With the Virtual Navigator, bronchoscopies can be planned better, more difficult sites can be biopsied, and fewer unsuccessful biopsies will be done. These benefits reduce the need for follow-up procedures, reducing cost and gaining time toward successful treatment, or, stated differently, improve the early diagnosis, staging, and treatment of lung cancer.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44CA091534-04
Application #
7007678
Study Section
Special Emphasis Panel (ZRG1-SRB (52))
Program Officer
Nordstrom, Robert J
Project Start
2001-06-28
Project End
2008-09-30
Budget Start
2006-02-01
Budget End
2008-09-30
Support Year
4
Fiscal Year
2006
Total Cost
$732,282
Indirect Cost
Name
Endographics Imaging Systems, Inc.
Department
Type
DUNS #
City
State College
State
PA
Country
United States
Zip Code
16801
Khare, Rahul; Bascom, Rebecca; Higgins, William E (2015) Hands-Free System for Bronchoscopy Planning and Guidance. IEEE Trans Biomed Eng 62:2794-811
Gibbs, Jason D; Graham, Michael W; Bascom, Rebecca et al. (2014) Optimal procedure planning and guidance system for peripheral bronchoscopy. IEEE Trans Biomed Eng 61:638-57
Merritt, Scott A; Khare, Rahul; Bascom, Rebecca et al. (2013) Interactive CT-video registration for the continuous guidance of bronchoscopy. IEEE Trans Med Imaging 32:1376-96
Graham, Michael W; Gibbs, Jason D; Higgins, William E (2012) Computer-based route-definition system for peripheral bronchoscopy. J Digit Imaging 25:307-17
Lu, Kongkuo; Taeprasartsit, Pinyo; Bascom, Rebecca et al. (2011) Automatic definition of the central-chest lymph-node stations. Int J Comput Assist Radiol Surg 6:539-55
Lu, Kongkuo; Higgins, William E (2011) Segmentation of the central-chest lymph nodes in 3D MDCT images. Comput Biol Med 41:780-9
Yu, Kun-Chang; Gibbs, Jason D; Graham, Michael W et al. (2010) Image-based reporting for bronchoscopy. J Digit Imaging 23:39-50
Graham, Michael W; Gibbs, Jason D; Cornish, Duane C et al. (2010) Robust 3-D airway tree segmentation for image-guided peripheral bronchoscopy. IEEE Trans Med Imaging 29:982-97
Gibbs, Jason D; Graham, Michael W; Higgins, William E (2009) 3D MDCT-based system for planning peripheral bronchoscopic procedures. Comput Biol Med 39:266-79
Merritt, Scott A; Gibbs, Jason D; Yu, Kun-Chang et al. (2008) Image-guided bronchoscopy for peripheral lung lesions: a phantom study. Chest 134:1017-26

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