University of Maryland Center of Excellence Dedicated to Brain Research
Maryland's "Brain Trust"
In recognition of their leadership in advancing focused ultrasound research for the brain, the Foundation is pleased to designate the University of Maryland as a Center of Excellence. The Chair of the Department of Neurosurgery, Howard Eisenberg, MD, and Chair of Diagnostic Radiology and Nuclear Medicine, Elias Melhem, MD, are managing a comprehensive bench-to-bedside program expanding the technology’s neurosurgical capabilities as well as innovating new methods for delivering therapies to the brain.
“The University of Maryland has created a dream team of experts in neurosurgery, neuroradiology, neurology, and biophysics that is collaborating to establish new frontiers to optimize the technology to treat a range of neurologic and psychiatric disorders,” says Foundation Chairman Neal F. Kassell, MD.
Both Eisenberg and Melham have a long-standing interest in focused ultrasound (FUS). Dr. Eisenberg has served as a consultant to the Foundation for over a decade. Dr. Melhem initially became aware of FUS when he was at the University of Pennsylvania and heard Ferenc Jolesz give a talk about 10 years ago. “This really captured my imagination for the potential of the technology,” says Melhem.
He was not able to obtain a system at Penn, but as he was being recruited to be Chairman of the Radiology Department at Maryland in 2012, he solicited support from the Dean of the School of Medicine to invest in creating a hub for focused ultrasound research. Since then he has invested in an Insightec Exablate clinical platform and basic science systems. The Departments of Radiology, Neurology and Neurosurgery have collaborated to create a multidisciplinary team of experts that has attracted more than $500,000 in research grants to date and laid a pipeline for future funding.
Virginia Governor Terry McAuliffe Visits Foundation
On August 22, Virginia Governor Terry McAuliffe visited the Focused Ultrasound Foundation and met with members of the Foundation’s Team, Board, Council, and leaders from the University of Virginia (UVA) Health System.
“We updated the Governor on the status of the technology,” said Foundation Chairman Neal F. Kassell, MD. “We also discussed the importance of ongoing Foundation-initiated focused ultrasound activities to the Commonwealth and the way in which state support has contributed to the development of the entire field.”
The UVA Focused Ultrasound Center is the Foundation’s first Center of Excellence created in 2009 through $8 million in investments from the Commonwealth of Virginia, the Foundation, UVA, Insightec, and GE. In subsequent years, the Commonwealth has invested an additional $7 million. The Commonwealth’s total investment of $11 million has attracted additional funding from the public and private sector in excess of $12 million.
This year, two returning students were met by a couple of new faces to round out our talented group of summer interns. One team employed 3D printing techniques to develop a therapeutic ultrasound system, which will be used in a Foundation-funded sonodynamic therapy research project at the University of Virginia (UVA). The others worked to develop new software and study techniques to improve safety and functionality.
“The projects the interns tackled have real-world applications not only locally at UVA but around the world. Their work will contribute to future research that helps drive this field forward,” says the Foundation’s Director of Extramural Research, Matt Eames, PhD.
Former Naval Air Intelligence Officer Contributes to Foundation
Impressing Jim Morley, an ex-Naval Air Intelligence Officer and founder and President of California Real Estate Management, is no small feat. But after learning about FUS in a TEDMED talk named “Healing Without Cuts,” Jim Morley was “enthralled” and soon became a donor to the Foundation. “The talk was my first experience to witness the revolution and possibilities of FUS,” said Jim. “I was blown away.”
Jim’s father-in-law died of a glioblastoma, so John Grisham’s book, The Tumor, resonated with Jim on a personal level. “Focused ultrasound rang my bell because this non-invasive technology could be applied to so many different types of diseases and conditions,” said Morley.
Foundation Earns Cancer Gold Standard Accreditation
The CEO Roundtable on Cancer has accredited the Foundation with the CEO Cancer Gold Standard, recognizing our efforts to reduce the risk of cancer for our employees. The initiative's mission focuses on three goals with regard to cancer: risk reduction, early detection, and quality care.
The CEO Roundtable on Cancer is a non-profit organization of the country’s leading CEOs founded in 2001 when the 41st President George H.W. Bush challenged a group of executives to “do something bold and venturesome about cancer within your own corporate families.”
Dr. Fountain will collaborate with UVA neurosurgeon Jeff Elias, MD, in conducting the procedures.
World's First Focused Ultrasound Clinical Trial for Epilepsy Begins
Researchers at UVA are starting the first clinical trial in the world using focused ultrasound to treat patients with epilepsy. The study, supported by the Focused Ultrasound Foundation in collaboration with the Epilepsy Foundation, will assess the feasibility, safety, and initial effectiveness of focused ultrasound to non-invasively destroy (ablate) diseased brain tissue that causes seizures.
The study is now recruiting up to 15 adult patients with a range of rare deep brain lesions that produce debilitating seizures that often do not respond to medications. It is expected that most patients in the study will have benign tumors in the hypothalamus, which can lead to frequent seizures with outbursts of spontaneous laughing, giggling, crying, or grunting; developmental delays and/or precocious puberty. The disorder can progress as patients age, leading to increased cognitive decline and severe behavior problems.
"We want to raise awareness of the potential to transform cancer treatment. Our ultimate goal is to translate that awareness into partnerships to advance the field toward widespread adoption." – Foley
In a feature published on the social journalism website Medium.com, Chief Scientific Officer, Jessica Foley, PhD, and Foundation Chairman Neal F. Kassell, MD, write about how focused ultrasound can enhance or replace surgery, radiation therapy, chemotherapy, and immunotherapy for cancer.
AAPM draws about 4,000 participants from the medical physics community.
Physicists in Medicine Meeting Report
Kullervo Hynynen, PhD, Professor of Medical Biophysics at the University of Toronto, presented a distinguished lecture at the American Association of Physicists in Medicine (AAPM) Annual Meeting. The lecture, entitled “Advances in Ultrasound Therapy,” explained the principles, technology, and techniques behind focused ultrasound and its clinical use for drug delivery. Additional FUS presentations included:
An expert panel discussed image-guided Interventions, covering major trends in surgical intervention, including FUS.
The Fox Chase Cancer Center presented five research abstracts on various studies using non-thermal, pulsed FUS for cancer therapy, including prostate cancer.
Scientists at the University of Michigan used focused ultrasound to release molecules from acoustically responsive scaffolds.
In a letter published in the journal Brain Stimulation, researchers at UCLA applied MR-guided low intensity focused ultrasound to the brain of a 25-year-old man who had suffered a traumatic brain injury and was in a minimally conscious state. Using a Brainsonix BXPulsar 1001 system, the team applied ten 30-seconds-on, 30-seconds-off sonications to the right thalamus.
Within a day after the procedure the patient began to reach for objects. Language comprehension was exhibited after 3 days, and by day 5 the patient attempted to walk. The report has garnered significant media attention around the world, including Life Science Daily, STAT News, and Science Magazine.
Wonhye Lee
3rd Quarter Research Award
Researchers from the Department of Radiology at Brigham and Women’s Hospital and the Neuromodulation and Tissue Engineering laboratory at Harvard University will study non-thermal focused ultrasound as a tool for transcranial neuromodulation. Wonhye Lee, PhD, and Seung-Schik Yoo, PhD, MBA, have received a Foundation Research Award for “FUS-mediated Neuromodulation from Unanesthetized Freely-moving Animals.”
The team will target the somatomotor area to examine the neuromodulatory outcome based on electrophysiological signals and motor behavioral responses to the sonication
"One of the primary hurdles for researchers to perform repeatable neuromodulation in animals has been the need to have very tight controls over anesthesia, as the method and degree of sedation affects an animal's response to the ultrasound stimulus," says the Foundation's Director of Extramural Research, Matt Eames, PhD. "The significant innovation of this project lies in the study design--the neuromodulation will be delivered in freely moving, awake subjects.".
The University of Maryland group has published a comprehensive review of focused ultrasound in neuro-oncology. For Emerging Applications of Therapeutic Ultrasound in Neuro-oncology: Moving Beyond Tumor Ablation, see Neurosurgery.
A Korean collaboration has determined that BBB opening with FUS decreases expression of a drug-resistance gene. For Localized Down-regulation of P-glycoprotein by Focused Ultrasound and Microbubbles induced Blood-Brain Barrier Disruption in Rat Brain, see Scientific Reports.
The Chongqing, China group has developed sonosensitive polymeric nanoparticles. For HematoPorphyrin Monomethyl Ether polymer contrast agent for ultrasound/photoacoustic dual-modality imaging-guided synergistic high intensity focused ultrasound therapy, see Scientific Reports.
JTU Article of the Month – Open Source Focused Ultrasound System for Research
The group at Vanderbilt University has published the directions for their open-source, small-animal, MR-guided FUS system in the Journal of Therapeutic Ultrasound. The platform has the capability to deliver precise and controlled sonications over extended periods of time. The system should increase opportunities for interdisciplinary researchers who have new ideas for using the technology to test their hypotheses.
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INDUSTRY NEWS
Theraclion Gets FDA Go Ahead for Breast Study
The US Food and Drug Administration has approved Theraclion’s request for an Investigational Device Exemption (IDE) to initiate a 100-patient study for breast fibroadenoma. The device will be developed via the 513(f)(2) pathway. This news was released along with a summary of their data from five studies demonstrating promising clinical results for the Echopulse focused ultrasound system.
First Patient Treated in Profound’s Pivotal Trial for Prostate Cancer
The first patient has been treated in Profound’s TACT (TULSA-PRO Ablation Clinical Trial) pivotal clinical trial for localized, organ-confined prostate cancer. The treatment in this 110-patient study was conducted at Vanderbilt University Medical Center.
TULSA-PRO combines real-time MR imaging with transurethral, robotically driven ultrasound and closed-loop thermal feedback control designed to provide precise ablation while protecting critical surrounding anatomy. Sites throughout the United States, Germany, Netherlands, Spain and Canada will participate in this trial.
In a Phase 1 clinical study, TULSA-PRO demonstrated accurate ablation of targeted prostate tissue, while providing a well-tolerated safety profile with minor impact on urinary, erectile and bowel function. The results of this study were just published in European Urology.
