In
Percutaneous Therapy Systems (Task 2.1),
there are six clinical trials approved, two pending, and another two
in preparation. We have obtained NIH grants for all of these projects
and some of those projects have grown to be a program in itself funded
from multiple grants. We have several major NIH and DoD grants pending.
In the prostate intervention program, we are pursuing a multitude of biopsy and
therapy modalities with both MRI and US guidance and with both transrectal and
transperineal access. Our MRI-guided prostate intervention program is funded from
three related RO1 grants. We have a Biomedical Research Partnership (BRP) proposal
pending to orchestrate MRI-guided prostate intervention activities together under
a common center grant. Another purpose of this BRP grant is to provide resources
for transfer of segmentation, registration and deformable modeling results from
Tasks 2.2 and 2.3. Another objective for the prostate program is to unite US-guided
prostate intervention research under a similar center grant.
The US-guided liver surgery and intervention program has expanded, with the active
participation of Siemens, Intuitive, and Acoustic MedSystems. We actively investigating
cross-cutting basic technologies, such as anatomical segmentation and therapy
monitoring with acoustic elastography imaging, and real-time in-vivo calibration
and quality assurance of ultrasound guided surgical systems. The initial results
were reported in several MICCAI papers. Another significant milestone was teaming
up with Intuitive Surgical for robot-assisted laparoscopic ultrasound imaging.
We completed a joint NIH grant to use the daVinci robot in laparoscopic liver
imaging (marking another point of convergence with the Surgical Assistants thrust)
and already filed a Phase-2 proposal.
The spine/bone intervention program has been pursuing a clinical trial approved
in year 6, in fractionated stereotactic radiosurgery of metastatic spine cancer.
The testbed for this builds on the purchase of equipment worth half a million
dollars by the Department of Radiation Oncology. This project also serves as the
testbed our research in 2D/3D bone registration and reconstruction pursued in
Task 2.5. We have obtained a joint NIH grant with Acoustic MedSystems for CT/CTF-guided
ultrasonic ablation of metastatic bone cancer. This project is uniting our industrial
partners novel therapeutic end-effector technology with the ERCs
strengths in image-guided surgical navigation. We also employ the CT image overlay
display technology for the guidance of biopsy of musculoskeletal tumors and joint
arthography, in collaboration with Siemens. An IRB application for human trials
and NHI proposal is in preparation to support this activity.
We have inaugurated at least one testbed for each major target organ system and
some testbeds span multiple organ systems, Each testbed drives research efforts
in systems integration and promotes sharing of enabling technology across testbeds.
The currently active testbeds include the following:
- Transrectal prostate interventions in closed MRI scanner. Presently in
two concurrent clinical trials at NIH., this testbed drives research in robot
development, MRI image analysis, and deformable organ modeling.
- Transperineal prostate interventions in open magnet MRI scanner. Presently
in two concurrent clinical trials at BWH., this testbed drives research in robot
development, MRI image analysis, and deformable organ modeling, and statistical
atlas-based optimization.
- Ultrasound-guided robot-assisted prostate interventions. Working with
two industry partners, this testbed drives research in robot development, image
analysis, and treatment optimization.
- Ultrasound-guided trans-abdominal prostate radiotherapy. In development
with an industry partner, this testbed drives research in US image processing.
- Spinal radiosurgery. Currently in a clinical trial, with an industry
partner, this testbed drives research in 2D/3D X-ray registration.
- Ultrasound guided hepatic thermal ablation. This involves technology
development with three industry partners and drives research in robot development,
robot control, and US image analysis.
- Musculoskeletal interventions with CT & MRI image overlay. An IRB
application is being prepared, working with an industry partner; this testbed
drives research in registration and surgical display technology.
- CT-guided robot-assisted needle placement in lung and spine. This project
is in a clinical trial at Georgetown University and drives research in robot development,
image analysis, motion tracking, and robot control.
There are several reasons for the emphasis and multiple projects involving prostate:
it is a worldwide health problem; there is strong faculty expertise; there are
committed clinical partners; we have strong industry participation; and there
is substantial external funding available. We are developing prostate biopsy and
therapy with two major imaging modalities (MRI and US), and exploring all clinically
established access routes: perineum, rectum, and abdomen. The MRI-guided leg of
our research has been in a total of four clinical trials, and the US-guided component
is to follow suit soon. We took a comprehensive approach embracing all aspects
of intraprostatic interventions known today, thereby creating unprecedented richness
in technical expertise and scientific data in the subject. The testbeds and clinical
trials involve multidisciplinary talents and draw expertise from all areas of
our disciplinary research (image analysis, modeling, device/robot development,
and system integration).
Each testbed has one or more clinical champions and industry partners, and each
receives funding from peer-reviewed government grants. In response to such input,
our testbeds are ever-changing to reflect the evolving nature of our field. For
example, we have reshaped our efforts in CT-guided percutaneous interventions
several times, reflecting the dramatic change that CT fluoroscopy has brought
into the field during the past few years.
Over time, as systems and technology develop, and as systems combining both Surgical
CAD/CAM and Surgical Assistants aspects emerge, we will develop
further appropriate testbeds. One example is a prospective testbed using high
dexterity robotic systems for minimally invasive debridment and repair of osteolysis
from bone cancer or around orthopaedic implants. Our testbeds also serve as valuable
training and educational vehicles. We routinely involve summer interns and REU
students in our work, under the supervision of our graduate research assistants
The CT image overlay clinical testbed has served as a hands-on experimental platform
in the Introduction for CIS pre-college course.