Award Abstract # 1819850
SBIR Phase I: Developing a Single-Visit System to Screen, Diagnose, and Treat Cervical Neoplasia

NSF Org: TI
Translational Impacts
Recipient: PENSIEVISION, INC.
Initial Amendment Date: July 16, 2018
Latest Amendment Date: July 16, 2018
Award Number: 1819850
Award Instrument: Standard Grant
Program Manager: Henry Ahn
hahn@nsf.gov
 (703)292-7069
TI
 Translational Impacts
TIP
 Directorate for Technology, Innovation, and Partnerships
Start Date: July 15, 2018
End Date: March 31, 2019 (Estimated)
Total Intended Award Amount: $224,289.00
Total Awarded Amount to Date: $224,289.00
Funds Obligated to Date: FY 2018 = $224,289.00
History of Investigator:
  • Joseph Carson (Principal Investigator)
Recipient Sponsored Research Office: Pensievision, Inc.
5965 VILLAGE WAY STE E105
SAN DIEGO
CA  US  92130-2475
(858)255-4529
Sponsor Congressional District: 50
Primary Place of Performance: Pensievision, Inc.
CA  US  92121-3717
Primary Place of Performance
Congressional District:
51
Unique Entity Identifier (UEI): FX8MZJECT715
Parent UEI:
NSF Program(s): SBIR Phase I
Primary Program Source: 01001819DB NSF RESEARCH & RELATED ACTIVIT
Program Reference Code(s): 5371, 8038
Program Element Code(s): 537100
Award Agency Code: 4900
Fund Agency Code: 4900
Assistance Listing Number(s): 47.084

ABSTRACT

This SBIR Phase I project will develop an innovative 3D medical imaging technology for early-stage detection and analysis of cancers, initially focusing on detecting pre-cancer cervical lesions. This project will advance from creatively assembling existing active optics hardware to inventing a new microfiber-based active optics system to circumvent limits of space confinement and 3D resolution. The project's fundamental strategy for identifying pre-cancers of the cervix, which relies on a macroscopic 3D digital analysis combined with microscopic cell evaluation, is naturally amenable to artificial intelligence technologies. The versatility of this imaging platform enables the resolving of medical diagnostic challenges in wealthy settings and the resolving of cost-saving barriers in resource-limited settings. The imaging technology can be extended beyond medical practice to other scientific and industrial disciplines. Potentially, this project has an immediate impact on saving lives and costs via the early detection of fatal diseases. Additionally, the data and knowledge acquired developing and implementing this imaging system provide opportunities to meaningfully develop new computational strategies for educational, engineering and industrial interests. The innovative, commercially viable, platform technology offers opportunities for significant, tax-revenue-generating global profits, for future technology application spin-offs, and for producing high technology jobs for U.S. citizens.

The project innovation will voyage from state-of-the-art 3D software development to the creation of a new type of fiber bundle imager with an electronically controlled actively focusing lens. Combined, these tasks achieve the creation of a miniaturized 3D imaging system capable of navigating confined spaces within the body, such as inside the cervix opening. For all prototypes developed for this project, final 3D renderings are enabled by proprietary 3D rendering software, capable of quantifying tissue color, volume and shape at the macroscopic level, while also evaluating cell size and approximate shape at the microscopic level. In wealthy settings, this system would be desirable for implementing a single-phase cervical cancer screening strategy to replace the current two-phase approach, which requires Pap smear and/or human papilloma virus assay, followed by the more expensive colposcopy in the case of an abnormal result. In resource-limited regions and/or regions with difficult-to-reach populations, where it is challenging to get patients to return for a follow-up visit, the technology would offer a low-cost, pre-screening method that only requires a single visit. This 3D imaging system could be combined in the future with a therapeutic agent administered at the time of diagnosis, thus offering a single-visit, screen-diagnose-and-treat method.

This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

PROJECT OUTCOMES REPORT

Disclaimer

This Project Outcomes Report for the General Public is displayed verbatim as submitted by the Principal Investigator (PI) for this award. Any opinions, findings, and conclusions or recommendations expressed in this Report are those of the PI and do not necessarily reflect the views of the National Science Foundation; NSF has not approved or endorsed its content.

     Pensievision has invented an innovative 3D medical imaging technology for early-stage detection and analysis of cervical cancers. As a pathway to demonstrating technical feasibility, and therefore likely commercial viability, we carried out in-lab demonstrations of our Level 1 prototype, CervImage (see Figure 1). With a diameter less than 2 cm, and a built-in illumination system, it is designed for a clinician to be able to insert it in the vagina to enable 3D imaging of the cervix. In parallel, we carried out the advanced design, fabrication, and initial proof-of-concept testing of a higher-risk Level 2 prototype (see Figure 2), which is a micro-fiber-based, active optics system, meant to be able to eventually enter ultra-confined (<2 mm diameter) spaces within the body, such as inside the cervix opening. With the two fabricated prototypes, final 3D images were successfully generated by our proprietary 3D rendering software, which is based on principles previously used for astronomy imaging. Our experimental measurements demonstrated that our technology is capable of quantifying tissue color, volume and shape at the macroscopic level (see Figure 3), while also being able to evaluate cell size and approximate shape at the microscopic level (see Figure 4). We also created a user-friendly graphical user interface, including virtual navigation tools to help the clinician properly position the camera (see Figure 5).

     The overall activities successfully demonstrated that the Pensievision technologies may in the future act as a critical imaging tool for enabling clinicians to be able to ?see? and evaluate an area of tissue that is inadequately screened with current technologies like Pap smears. During the grant period, important technical hurdles were successfully overcome, including previous problems such as image distortions, insufficient range of active optics focus, and rupturing of focus lens. As a result of the NSF-support activities, major advances were made toward the goal of developing simple, cost-effective, early detection technologies, accessible to everyone to prevent unnecessary deaths caused by a lack of screening.

    Pensievision?s technology is focused on preventing cancers of the cervix. Cervical cancer is the third most common cancer worldwide, with 85% of cases occurring in areas lacking effective screening programs aimed at detecting and treating precancerous lesions. In the developing world, where resources and medical infrastructure are limited, and it is a challenge to get patients to return for a follow-up visit, Pensievision?s technology could be used as a replacement for the Pap smear and HPV test, offering a pre-screening method that only requires a single visit. In wealthy parts of the world, the technology would be desirable because it is inexpensive enough, effective enough, and sufficiently easy to use by a non-expert.


Last Modified: 04/22/2019
Modified by: Joseph Carson

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