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The Novel Biopsy Needle Design and Delivery System to Minimize Needle Deflection and Optimize Needle Positioning to Improve Lesion Sampling Accuracy Using a Co-registered MRI/US Fusion Biopsy Platform

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41CA228877-01
Agency Tracking Number: R41CA228877
Amount: $172,437.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 101
Solicitation Number: PA17-303
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-08-01
Award End Date (Contract End Date): 2019-07-31
Small Business Information
Ann Arbor, MI 48103-2182
United States
DUNS: 962084146
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 (419) 215-4066
Business Contact
Phone: (734) 846-8991
Research Institution
ANN ARBOR, MI 48109-5001
United States

 Nonprofit College or University

Project Abstract
Accurate diagnosis of prostate cancer is essential for individualized treatment decisionsWith more recent
advances in multiparametric magnetic resonance imagingmpMRIsuspicious cancer lesions can be identifiedCo registered MRI ultrasound fusion targeted biopsyMRF TBallows the sampling of specific lesions of
concern within the prostate has emerged as the preferred diagnostic procedure for men presenting with a
concern for prostate cancerAs the use of targeted prostate biopsy techniques expandsa biopsy needle that
can accurately and reproducibly obtain tissue samples from the targeted sites along the anticipated biopsy path
is crucial for high diagnostic accuracyThe biopsy needles currently available do not meet this needTargeted
prostate biopsy procedure has two phasesIneedle positioning andIIneedle firingThe current needle
delivery process and needle design cause the undesired intraoperative prostate movement in Phase I and
significant needle deflection in Phase IImaking the desired biopsy core trajectory difficult to achieveThis leads
to variance in the targeted and actual locations of the obtained acquired tissue coreSuch sampling errors result
in a lesion undersamplingfalse negative results and misdiagnosisThis research aims to establish the
effectiveness of our novel prostate needle biopsy device designed specifically to optimize lesion sampling
accuracy in co registered MRF TBTo reduce sampling errors in Phase IIwe developed a dual bevel stylet tipIn a preliminary biopsy study using the prostate like tissue phantomthis stylet tip reduced needle deflection bywhen compared to the current needle design and demonstrated the sequentially equivalent core length
using a commercial biopsy actuation deviceTo account for the prostate movement in Phase Iwe developed a
mosquito proboscis inspiredMPIneedle with incremental needle stylet motion and micro notched styletThe
MPI needle can reduce the targeted organ movement by up top andltin a prostate like tissue phantom
when compared to the current needle delivery processThe aforementioned innovations demonstrate greater
needle sampling accuracy when compared to the current industry standard needlesThis research proposes to
combine these innovations in a novel prostate needle biopsy device to demonstrate the optimal sampling
accuracy and acquire adequate preclinical validationThis research will have significant impact on patients
presenting with a concern for prostate cancerOur innovations will reduce false negative biopsy results and
increase the biopsy diagnostic accuracy with a more expedient and less traumatic biopsy procedureThe
proposed technique may further benefit other organ biopsy procedurese gthe liver biopsyas well as other
clinical practices requiring precise needle deployment Project Narrative
This research aims to achieve the precision needle positioning to optimize the lesion sampling accuracy for
accurate prostate cancer diagnosis in co registered magnetic resonant imaging and ultrasound fusion prostate
targeted biopsy

* Information listed above is at the time of submission. *

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