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Intra-procedure Deformable Ultrasound-MRI Fusion for Prostate Biopsies

Award Number: R42CA186414
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/11/2014
PERIOD OF PERFORMANCE END DATE: 06/30/2018

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Intra-procedure Deformable Ultrasound-MRI Fusion for Prostate Biopsies - This Phase II proposal is a continuation of our successful Phase I grant whose overarching goal is to develop a more robust and accurate method for the deformable fusion of pre-operative magnetic resonance images (MRI) and intra-procedure trans-rectal ultrasound (TRUS) images to guide prostate biopsy. Prostate cancer is a major cause of death in the U.S. and biopsy is the gold-standard for its diagnosis. Each year over 1.1 million biopsies are performed in the U.S. alone at a cost of well over $1 billion. Most of these biopsies are performed under TRUS guidance in a systematic fashion but blinded to potential tumor locations because many tumors are invisible on ultrasound. This procedure is highly inefﬁcient and as many as 30% of serious tumors may be missed on a ﬁrst- time biopsy. Multi-parametric MRI (mpMRI) acquired before the biopsy can be used to deﬁne potential targets and then used in conjunction with live TRUS imaging to perform targeted image-guided biopsy. A key challenge is the accurate registration (fusion) of the intra-procedure TRUS with the pre-acquired MRI. This fusion procedure is often performed using rigid registration which does not account for prostate deformation between the MRI and TRUS acquisitions. Eigen's Artemis system is one of a newer generation of devices that performs deformable mapping between MRI and TRUS. Current fusion methods (such as in Artemis), however, are highly operator dependent as they rely on semi-automated TRUS segmentation by the clinician during the procedure which is error prone, time-consuming and critically reliant on operator skill. We propose to extend the development of our strategy for deformable registration (from Phase I) based on a statistical deformation model learned from an existing, large, multi-institutional database (N=200) of MRI-TRUS prostate image pairs. We will learn the statistics of both biopsy deformation and prostate shape clusters. The model will reduce the dimensionality of the search as well as constrain the deformation. The proposed registration method will use a regional conﬁdence estimate for the intra-procedure interactive TRUS segmentation in order to enhance robustness by focusing the registration on the more conﬁdent portions of the bounding surface. We will also generate regional anisotropic estimates of registration uncertainty. These methods will streamline the clinician's workﬂow by providing a more accurate and robust registration with less dependence on segmentation errors. This project is signiﬁcant in that it has the potential to improve the utilization of MRI-TRUS fusion guided prostate biopsy (especially outside of major academic hospitals) by alleviating the dependence of the workﬂow on exact prostate segmentation from often poor quality TRUS images. In Aim 1, we will further improve our fusion algorithm, integrate it into the Artemis system and test for improved accuracy. In Aim 2, we will create an innovative research interface to our new algorithm to allow for clinical testing and then perform a two-site clinical validation in N=40 patients. We will compare our new method to the current non-rigid MRI-TRUS fusion method used in our FDA-cleared Artemis system to demonstrate improved accuracy.


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: 2020 ( Subtotal = $0 )
2020	2017	ZMK MEDICAL TECHNOLOGIES, INC.	13366 GRASS VALLEY AVE STE A	GRASS VALLEY	CA	95945	NEVADA	USA	Cancer Detection and Diagnosis Research	000	4	12/9/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $491,366 )
2017	2017	ZMK MEDICAL TECHNOLOGIES, INC.	13366 GRASS VALLEY AVE STE A	GRASS VALLEY	CA	95945	NEVADA	USA	Cancer Detection and Diagnosis Research	002	4	6/30/2017	NON-COMPETING CONTINUATION	$491,366
2017	2016	ZMK MEDICAL TECHNOLOGIES, INC.	13366 GRASS VALLEY AVE STE A	GRASS VALLEY	CA	95945	NEVADA	USA	Cancer Detection and Diagnosis Research	000	2	1/25/2017	COMPETING CONTINUATION	-$509,295
2017	2016	ZMK MEDICAL TECHNOLOGIES, INC.	13366 GRASS VALLEY AVE STE A	GRASS VALLEY	CA	95945	NEVADA	USA	Cancer Detection and Diagnosis Research	001	3	1/26/2017	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$509,295
														Subtotal = $491,366

Issue Date FY: 2016 ( Subtotal = $509,295 )
2016	2016	IGT LLC DBA EIGEN	13366 GRASS VALLEY AVENUE	GRASS VALLEY	CA	95945	NEVADA	USA	Cancer Detection and Diagnosis Research	000	2	7/14/2016	COMPETING CONTINUATION	$509,295
														Subtotal = $509,295

Grand Total All Awards = $1,000,661

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Intra-procedure Deformable Ultrasound-MRI Fusion for Prostate Biopsies

Award Number: R42CA186414

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/11/2014

PERIOD OF PERFORMANCE END DATE: 06/30/2018

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