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Development and testing of MRI-mediated radiofrequency ablation system and probes

Award Number: R44CA203276
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/05/2016
PERIOD OF PERFORMANCE END DATE: 12/31/2019

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Development and testing of MRI-mediated radiofrequency ablation system and probes - Project Summary/Abstract Radiofrequency ablation (RFA) is a minimally invasive method used to treat solid tumors, commonly primary liver cancers and metastases, which are accessible percutaneously via a sharp needle. Imaging guidance, typically by ultrasound or CT, is required for probe placement, but these methods are incapable of monitoring the progress of the procedure. Additional imaging sessions are required to initially locate the tumor and to assess the effectiveness of the therapy. The overall goal of this project is to translate into clinical practice a novel MRI-mediated RFA therapy. In this method, RF energy is provided and controlled by the MRI scanner, eliminating the need for an external RF generator and a grounding pad. The MRI scanner additionally offers superior soft tissue contrast for tumor localization and real time guidance of RF probe placement using a commercial gradient-based navigation system. Additionally, monitoring of tissue (rather than probe) temperature is possible during the procedure, permitting immediate assessment of the success of the ablation. Eliminating the grounding pad reduces the possibility of patient burns, and therefore increases patient safety. An initial R21 exploratory grant funded basic discovery research into this technology, comprising theoretic, scientific and technical development of MRI-mediated RFA, resulting in the demonstration of proof of principle in phantoms, tissue specimens, animal cadavers and live animals. The purpose of the current project is to translate these basic findings into a safe and practical system for clinical use, and to conduct a human clinical pilot project to assess if a full clinical trial is warranted. Specific aims include: 1- Develop integrated biopsy and RFA probes for MRI-mediated RF ablation. 2 - Optimize the performance of MRI-mediated RFA in phantom study. 3 - Optimize performance and safety of MRI-mediated biopsy and RFA in an animal study. 4 - Conduct the required regulatory activities needed to enable human study of the system. 5 - Perform pilot study in humans with liver cancer to be treated by chemotherapy. The long term goal of the research is to develop a time-efficient, cost-effective, minimally invasive “one-stop shop” treatment for solid tumors treatable by thermal ablation. If successful, it will provide a powerful diagnostic and therapeutic tool that can be used on any MRI scanner with low cost disposable devices and without the need to add major external apparatus. This is expected to facilitate the use of MRI-guided RFA to treat a wide range of tumors as a replacement for more invasive and more costly surgical management, contributing to the PHS mission of improving health care delivery while reducing cost and patient discomfort.


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	ROBIN MEDICAL, INC.	6607 BONNIE RIDGE DR APT 101	BALTIMORE	MD	21209	BALTIMORE CITY	USA	Cancer Detection and Diagnosis Research	000	2	7/29/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2017	ROBIN MEDICAL, INC.	3502 GARDENVIEW RD	PIKESVILLE	MD	21208	BALTIMORE	USA	Cancer Detection and Diagnosis Research	000	2	5/23/2019	NON-COMPETING CONTINUATION	$0
2019	2017	ROBIN MEDICAL, INC.	3502 GARDENVIEW RD	PIKESVILLE	MD	21208	BALTIMORE	USA	Cancer Detection and Diagnosis Research	001	2	6/27/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $749,102 )
2017	2017	ROBIN MEDICAL, INC.	3502 GARDENVIEW RD	PIKESVILLE	MD	21208	BALTIMORE	USA	Cancer Detection and Diagnosis Research	000	2	8/31/2017	NON-COMPETING CONTINUATION	$749,102
														Subtotal = $749,102

Issue Date FY: 2016 ( Subtotal = $749,066 )
2016	2016	ROBIN MEDICAL, INC	6607 BONNIE RIDGE DRIVE	BALTIMORE	MD	21209	BALTIMORE CITY	USA	Cancer Detection and Diagnosis Research	000	1	9/5/2016	NEW	$749,066
														Subtotal = $749,066

Grand Total All Awards = $1,498,168

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Development and testing of MRI-mediated radiofrequency ablation system and probes

Award Number: R44CA203276

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/05/2016

PERIOD OF PERFORMANCE END DATE: 12/31/2019

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