Image guided intervention system for pancreatic cystic lesions

Period of Performance: 09/01/2011 - 08/31/2013

$658K

Phase 2 SBIR

Recipient Firm

Physical Sciences, Inc.
ANDOVER, MA 01810
Principal Investigator

Abstract

DESCRIPTION (provided by applicant): This proposal addresses a need for an improved technology for both diagnosis and treatment of patients with cystic neoplasms of the pancreas. Currently, endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) technology is used as a first line of diagnosis for pancreatic lesions. However, the complex regional anatomy of the pancreas and the very difficult differentiation between various cystic lesions make the diagnosis of pancreatic cysts in general and the distinction between benign and malignant cysts in particular difficult without surgical resection. Physical Sciences Inc. (PSI) has developed a technology that shows promise for increasing the diagnostic accuracy of the EUS-FNA procedures. In addition to cytopathological analysis, the clinician and pathologist will also benefit from the availability of high-resolution optical coherence tomography (OCT) images showing the in-situ morphology of the cyst lining. These images will be taken with a catheter that can be launched through the existing EUS needle. This technology can also provide a non-surgical therapeutic option for early stage lesions or for patients that are not surgical candidates. A therapeutic beam can be sent through the same OCT imaging catheter to thermally coagulate (necrose) the cyst epithelial lining. With the laser therapy and OCT imaging combined, the dual capability system has the potential for performing both diagnosis and real-time monitored therapy at the micron scale. None of these features are currently available to the physician. In Phase I a pre-clinical system was developed and a pilot in vitro clinical study on pancreatic tissue specimens was conducted to demonstrate the capability of the system for differentiating between cystic lesions (benign versus malignant and serous versus mucinous). Over 90% differentiation accuracy was obtained in this study. Real-time monitored thermal coagulation of pancreatic cysts was demonstrated as well. To the best of our knowledge, this is the most detailed OCT study on pancreatic lesions ever reported. The Phase II program will focus on the development of an advanced clinical prototype and imaging/therapy probe suitable for in vivo use, on conducting a pilot study on human patients to test the in vivo efficacy of OCT for cystic lesions differentiation, and on conducting a clinical study on animals to determine the in vivo efficacy of OCT monitored laser therapy. These studies will be performed at the Massachusets General Hospital, gastroenterology and animal facility suites. PUBLIC HEALTH RELEVANCE: The proposed research could substantially improve cancer diagnosis and therapy surveillance, allowing for detection at an early stage when it is treatable and potentially curable. It could also offer a potential therapeutic capability that might reduce the number of surgical interventions. It is evident that earlier diagnosis and therapy result in an improved outcome, decreased morbidity and reduced mortality from disease.