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Intraoperative Near-Infrared Fluorescence Imaging

Award Number: R01CA115296
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/29/2005
PERIOD OF PERFORMANCE END DATE: 08/31/2016

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Intraoperative Near-Infrared Fluorescence Imaging - DESCRIPTION (provided by applicant): Our hypothesis is that near-infrared (NIR) fluorescence has the potential to revolutionize image-guided surgery. At the beginning of our first award period, there were neither optimized imaging systems nor optimized contrast agents to test this hypothesis. Nevertheless, in only 31/2 years, our Bioengineering Research Partnership (BRP), comprised of the Frangioni Laboratory at the Beth Israel Deaconess Medical Center (BIDMC), GE Healthcare, and Siemens Corporate Research, has designed, constructed, and disseminated the FLARE (Fluorescence-Assisted Resection and Exploration) intraoperative NIR fluorescence imaging system. By exploiting several innovations in hardware and software, FLARE is capable of visualizing two independent channels of NIR fluorescence in real-time, with high sensitivity and resolution, and simultaneously with surgical anatomy. In addition to validating the technology in over 200 rodent and 100 large animal surgeries, we have exceeded the original Specific Aims by translating FLARE to the clinic where it is now being used in three separate, NIH-funded clinical trials in breast cancer SLN mapping, lung cancer SLN mapping, and perforator vessel mapping. We have also leveraged our resources to add the Patonay/Strekowski Laboratory at Georgia State University (GSU), recognized leaders in NIR fluorophore chemistry, to our BRP and with them have developed ultra-low background heptamethine indocyanines for potential clinical translation. Despite these advances, there remain four fundamental areas in the field that require ongoing investigation: 1) the development of minimally-invasive (e.g., laparoscopy/endoscopy) NIR fluorescence technology for the approximately 50% of human surgeries that are no longer performed using "open" incisions, 2) the addition of spatially-modulated light capabilities to quantify tissue optical properties, especially tissue oxygenation, in the absence of exogenous NIR fluorophores, 3) the addition of fluorescence lifetime imaging (FLIM) capability to FLARE to improve separation of exogenous NIR fluorophores from tissue autofluorescence, and 4) the first-in-human testing of novel NIR fluorophores that will lay the foundation for future disease-specific contrast agents. We focus the Specific Aims of this competing renewal application on these four key areas, and have updated our BRP to include Qioptiq LINOS, Inc., experts in optical engineering, Yankee Modern Engineering, experts in medical device mechanical engineering, Albright Technologies, Inc., experts in micro-fabrication and silicone heat dissipation technology, the Electronics Design Facility of Boston University, experts in laser control electronics and digital light processing (DLP), and Seres Laboratories, one of the few cGMP chemistry contractors with experience in producing heptamethine indocyanines. GSU will continue to assist with cGMP scale-up. Finally, we propose to intensify clinical translation activities during the second award period, including first-in-human trials of the engineering and chemistry innovations that arise from this BRP.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2017 ( Subtotal = $0 )
2017	2014	CURADEL, LLC	257 SIMARANO DR STE 100	MARLBOROUGH	MA	01752	MIDDLESEX	USA	Cancer Detection and Diagnosis Research	000	10	12/22/2016	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2014 ( Subtotal = $1,709,724 )
2014	2014	CURADEL LLC	377 PLANTATION STREET	WORCESTER	MA	01605	WORCESTER	USA	Cancer Detection and Diagnosis Research	001	10	9/23/2014	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,709,724
2014	2013	BETH ISRAEL HOSPITAL	330 BROOKLINE AVENUE	BOSTON	MA	02115	SUFFOLK	USA	Cancer Detection and Diagnosis Research	000	9	9/4/2014	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,709,724

Issue Date FY: 2013 ( Subtotal = $1,362,767 )
2013	2013	BETH ISRAEL HOSPITAL	330 BROOKLINE AVENUE	BOSTON	MA	02215	SUFFOLK	USA	Cancer Detection and Diagnosis Research	000	9	6/12/2013	NON-COMPETING CONTINUATION	$1,362,767
														Subtotal = $1,362,767

Issue Date FY: 2012 ( Subtotal = $1,439,566 )
2012	2012	BETH ISRAEL HOSPITAL	330 BROOKLINE AVENUE	BOSTON	MA	02215	SUFFOLK	USA	Cancer Detection and Diagnosis Research	000	8	7/3/2012	NON-COMPETING CONTINUATION	$1,439,566
														Subtotal = $1,439,566

Issue Date FY: 2011 ( Subtotal = $1,467,630 )
2011	2011	BETH ISRAEL HOSPITAL	330 BROOKLINE AVENUE	BOSTON	MA	02215	SUFFOLK	USA	Cancer Detection and Diagnosis Research	000	7	6/28/2011	NON-COMPETING CONTINUATION	$1,467,630
														Subtotal = $1,467,630

Issue Date FY: 2010 ( Subtotal = $1,599,053 )
2010	2010	BETH ISRAEL HOSPITAL	330 BROOKLINE AVENUE	BOSTON	MA	02215	SUFFOLK	USA	Cancer Detection and Diagnosis Research	000	6	8/20/2010	COMPETING CONTINUATION	$1,599,053
														Subtotal = $1,599,053

Issue Date FY: 2009 ( Subtotal = $1,235,683 )
2009	2009	BETH ISRAEL HOSPITAL	330 BROOKLINE AVENUE	BOSTON	MA	02215	SUFFOLK	USA	Cancer Detection and Diagnosis Research	000	5	5/29/2009	NON-COMPETING CONTINUATION	$1,235,683
														Subtotal = $1,235,683

Issue Date FY: 2008 ( Subtotal = $1,217,958 )
2008	2008	BETH ISRAEL HOSPITAL	330 BROOKLINE AVENUE	BOSTON	MA	02115	SUFFOLK	USA	Cancer Detection and Diagnosis Research	000	4	6/30/2008	NON-COMPETING CONTINUATION	$1,217,958
														Subtotal = $1,217,958

Issue Date FY: 2007 ( Subtotal = $1,241,997 )
2007	2007	BETH ISRAEL HOSPITAL	330 BROOKLINE AVENUE	BOSTON	MA	02115	SUFFOLK	USA	Cancer Detection and Diagnosis Research	000	3	7/30/2007	NON-COMPETING CONTINUATION	$1,241,997
														Subtotal = $1,241,997

Issue Date FY: 2006 ( Subtotal = $1,258,102 )
2006	2006	BETH ISRAEL HOSPITAL	330 BROOKLINE AVENUE	BOSTON	MA	02115	SUFFOLK	USA	Cancer Detection and Diagnosis Research	000	2	8/1/2006	NON-COMPETING CONTINUATION	$1,258,102
														Subtotal = $1,258,102

Issue Date FY: 2005 ( Subtotal = $1,326,280 )
2005	2005	BETH ISRAEL HOSPITAL	330 BROOKLINE AVENUE	BOSTON	MA	02115	SUFFOLK	USA	Cancer Detection and Diagnosis Research	000	1	9/29/2005	NEW	$1,326,280
														Subtotal = $1,326,280

Grand Total All Awards = $13,858,760

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Intraoperative Near-Infrared Fluorescence Imaging

Award Number: R01CA115296

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/29/2005

PERIOD OF PERFORMANCE END DATE: 08/31/2016

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