Harnessing low-field MRI and robotics to enable personalized incisionless prostate surgery

PROJECT SUMMARY/ABSTRACT Objective: The overarching goal of our research is to replace invasive radical prostatectomy with targeted, mini- mally invasive image-guided focal resection of prostate cancer. We propose to accomplish this by combining novel low-field MRI techniques with a new kind of surgical robot capable of delivering two needle-sized manipulators

into the prostate through a standard transurethral endoscope. Significance: 1 in 8 men will be diagnosed with prostate cancer in their lifetime, and it is second only to lung cancer in the number of men it kills every year in the USA. The gold standard treatment, radical prostatectomy, involves complications including all those of major surgery, as well as high rates of impotence and incontinence.

Recently, pioneering surgeons have noted the promise of patient-specific transurethral focal resection to reduce complication rates. However the approach is currently fundamentally limited by the fact that cancerous tissue cannot be visually differentiated from healthy tissue in endoscope images, forcing the surgeon to “guess” where

the cancer is, based on memory of preoperative MRI images. Ultrasound-MRI fusion cannot improve things, since the ultrasound probe compresses the prostate, which collapses the urethra and precludes transurethral interventions. We propose to eliminate the guesswork and enable accurate, precise, personalized focal resections

by fusing high-resolution preoperative MRI with intraoperative low-field MRI and a novel robotic system. Innovation: The central innovation of this project is to enable use of the emerging generation of inexpensive, portable, and open low-field MRI scanners to guide focal prostate resection. Additional innovation comes from

the robotic system which will enable precise and accurate use of imaging information. The robot will be the first MRI-conditional robot able to deliver multiple manipulators through an endoscope. It will feature needle- sized, tentacle-like manipulators and deploy them into the prostate through a standard-diameter transurethral

endoscope, for precise resection and retraction of tissue. This will make the focal resection process much easier and more accurate for the surgeon to accomplish. Approach: We will create our MRI-guided robotic system through three Specific Aims. Aim 1 achieves fast in- traoperative imaging to update the surgeon's image guidance display as they remove tissue. In Aim 2 we build

a novel MRI-conditional robot and integrate it with the low-field MRI scanner. In Aim 3 we validate the integrated system in anthropomorphic phantoms with urologic surgeons. Note that clinical translation of our system will be rapid at the successful conclusion of this R01. This project includes two industry partners, Promaxo, Inc. which

has recently released an FDA-approved low-field prostate MRI scanner, and Virtuoso Surgical, Inc. which is de- veloping a (non-MRI-conditional) transurethral robot slated to be on the market by the time this R01 concludes. Thus, successful completion of this R01 will pave the way for commercial translation and clinical trials, enabling

us to rapidly bring the benefits of this research to doctors and their patients.