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An Intraoperative Guidance Platform for Radio Frequency Ablation

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44CA189515-02A1
Agency Tracking Number: R44CA189515
Amount: $1,602,091.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 102
Solicitation Number: PA18-591
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-09-08
Award End Date (Contract End Date): 2021-08-31
Small Business Information
Burlington, MA 01803-1415
United States
DUNS: 078850424
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (603) 676-7450
Business Contact
Phone: (857) 880-2028
Research Institution

Project Summary:
The objective of this proposed research program is to develop a platform for planning and guidance during
Radio Frequency Ablation (RFA). RFA is a thermally mediated ablation technique, where an applicator carrying
one electrode is inserted into tumors percutaneously (or via laparoscopy, or open surgical approaches). Radio
Frequency (RF) energy is applied, denaturating and coagulating tissues in a volume of 2cm to 5cm of
diameter. Some RFA electrodes are shaped as straight needles; others deploy an umbrella of tines to ablate a
larger volume. RFA is attractive as it can be used percutaneously resulting minimally invasive. RFA is a widely
accepted cancer treatment therapy, and is applied to primary and secondary tumors in different organs,
including liver, lung, kidney, breast, and in musculoskeletal interventions. RFA is often the preferred treatment
option for inoperable patients.
The typical approach for RFA is percutaneous. Physicians therefore have no direct view of the location of
electrodes and of tissues. CT and Ultrasound are used intraoperatively to track the location of electrodes, but
both CT and Ultrasound (US) have limited ability to visualize the necrotization of tissues under RFA. It is hard
therefore to assess which tissues have been treated and which not. Currently physicians rely on “mental maps”
of where they have previously ablated tissues and estimate where to go next. The necrotization volume is also
“mentally estimated” from lesion geometry charts provided in print by electrode manufacturers. These charts
show the expected ablation geometry for a uniform tissue and do not account for the anatomy or the presence
of blood vessels, which can modify and reduce the ablation volume as they transport heat away.
The overarching goal of this program is to develop a platform for pre-operative planning and intraoperative
RFA guidance, based on simulation of the electrical / thermal effects of RFA and real-time intraoperative
prediction of necrotization patterns. Image fusion of RFA simulations onto CT intraoperative images would
constitute a guidance system able to show which tissues have been treated and which not, allowing the
physicians to properly repositions electrodes and achieve consistent overlap. This would improve outcomes of
RFA particularly for patients with tumors greater than 2cm, for which total necrotization has been shown to be
particularly hard to achieve without guidance.Project Narrative:
This program aims at developing a platform for planning and intraoperative image guidance during Radio
Frequency Ablation (RFA), an ablation technique based on the application of Radio Frequency energy to the
tissues by using needle-electrodes that are inserted into the tumors. In percutaneous interventions it is hard for
physicians to estimate which tissues have been treated and which not, as current imaging technologies (CT,
Ultrasound) do not show well treated tissues during RFA. We propose to use computer models predicting the
ablation geometry and to superimpose them to intraoperative CT images, to guide the intervention and
facilitate uniform and complete necrotization of target tissues.

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

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