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Focused Ultrasound Treatment Comparable to Radiation Therapy for Patients with Painful Bone Metastases

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Key Points Prof. Alessandro Napoli and his team at Sapienza University of Rome conducted a comparative phase II clinical trial that enrolled 198 participants with painful bone metastases. When compared with external beam radiation therapy (EBRT), focused ultrasound produced a faster and better pain control response that lasted longer than EBRT. An accompanying editorial praised focused ultrasound as a promising new advance in interventional oncology and suggested that future comparative trials follow this study model as a practical approach to adopting innovative new treatments. Focused Ultrasound and External Beam Radiation Therapy for Painful Bone Metastases: A Phase II Clinical Trial Prof. Alessandro Napoli and his team at Sapienza University of Rome conducted a comparative, nonrandomized, phase II clinical trial that enrolled 198 participants with painful bone metastases. The study compared the safety and effectiveness of treating the bone metastases with focused ultrasound or EBRT. Beyond numeric pain rating scales at 1- and 12-months following treatment, the open-label protocol also included assessment of quality-of-life measures and analysis of adverse events. Focused ultrasound had statistically significant higher overall response rates than EBRT at both 1- and 12-months post procedure and statistically significant lower overall adverse event rates. The authors concluded that focused ultrasound was comparable to EBRT for improving pain palliation and quality of life. In an accompanying editorial, “Radiation Therapy Castle Under Siege: Will It Hold or Fold?” Alexis Kelekis, MD, PhD, EBIR, FSIR, FCIRSE, said that focused ultrasound was among several new advances in interventional oncology for providing local energy deposition. He noted some of the current disadvantages of focused ultrasound (e.g., it is a long and tiring single-session treatment that requires anesthesia) but said that the technology’s absence of ionizing radiation and better overall results than EBRT for treating bone metastases make it “a promising alternative for the future.” After describing that the partial response rate in the study favored EBRT, Dr. Kelekis added, “Perhaps the future lies in combined therapies and hybrid techniques trying to bridge and exploit the advantages of each therapeutic approach.” He went on the praise the study design and suggested that the model should be adopted by more researchers to increase the use of innovative and novel therapies that provide real hope to patients. Suzanne LeBlang, MD, the Foundation’s Director of Clinical Relationships, has known Dr. Napoli for nearly 16 years. She says, “Dr. Napoli was one of the early pioneers in the field, and this important paper adds to the mounting body of knowledge about the benefits of focused ultrasound. Moving forward, we are hopeful that others will perform seminal research projects and publish findings for other indications because focused ultrasound is a platform technology that has widespread applicability to other diseases.” See Radiology > See Dr. Kelekis’ Editorial > See Media Coverage of the Study: Medpage Today
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Focused Ultrasound Now FDA Approved to Treat Essential Tremor Patients’ Second Side

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Key Points Patients with essential tremor can now have their second side treated with focused ultrasound. ET commonly affects both sides of the body, and to date, focused ultrasound was only approved for unilateral treatments. The ruling was based on data that showed a highly significant reduction in tremor following treatment of the second side. The US Food and Drug Administration (FDA) will now allow appropriate patients with essential tremor (ET) to have focused ultrasound treatment on the second side of their brain. ET is the most common movement disorder, affecting an estimated 3% of the population, or approximately 10 million individuals in the US. It is often viewed as a relatively benign disease, but it can have substantial effects on quality of life for many patients. The disorder commonly affects both sides of the body. In July 2016, the FDA cleared Insightec’s Exablate Neuro focused ultrasound device to treat one side of the brain, generally the side that alleviates tremors on the patient’s dominant side. Now, patients who have undergone focused ultrasound treatment on one side can have the second side treated at least nine months after the initial procedure. This “second side” procedure may also be referred to as bilateral treatment. According to an Insightec press release, the ruling was based on data from a study that showed a highly significant reduction in tremor following treatment of the second side. Learn more about that trial > Focused ultrasound is also being investigated in clinical trials for the bilateral treatment of Parkinson’s disease. Read the Insightec Press Release > Meet Tom Tom was thrilled when he was invited to participate in a clinical trial to receive a second focused ultrasound procedure to address the tremor in his non-dominant hand. Tom and his brother Phil talk about their experience with focused ultrasound and their hope that the technology can become more readily available for others, including many in their extended family who have also been affected by ET.
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Meeting Report: American Epilepsy Society (AES) 2022

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Key Points The 2022 Annual Meeting of the AES was held December 2–6 in Nashville, Tennessee. Harvard neurologist Ellen Bubrick, MD, led a special session on “Focused Ultrasound: A Rapidly Growing, New Approach to Epilepsy Treatment.” The workshop described how various mechanisms of action of focused ultrasound can be used in the treatment of many types of epilepsy. The 2022 Annual Meeting of the AES was held December 2–6 in Nashville, Tennessee. As one of the oldest neurological professional organizations in the United States, AES holds the largest worldwide meeting and exhibition for scientific and clinical research on epilepsy and clinical neurophysiology. On Sunday, December 4, Ellen Bubrick, MD, assistant professor of neurology at Harvard Medical School and associate neurologist in the Department of Neurology at Brigham and Women’s Hospital, led a special session on focused ultrasound at the meeting. The session was an Investigators Workshop titled “Focused Ultrasound: A Rapidly Growing, New Approach to Epilepsy Treatment.” Along with Dr. Bubrick, the expert panel included Raag Airan, MD, PhD (Stanford University), Charles Caskey, PhD (Vanderbilt University), and Vibhor Krishna, MBBS, MS (the University of North Carolina). The workshop described how focused ultrasound can be used for ablative (high intensity) or neuro-modulatory (low intensity) effects in the treatment of many types of epilepsy. It also covered current clinical trials for ablation and neuromodulation in epilepsy and promising preclinical studies that are using focused ultrasound to open the blood-brain barrier (BBB) for targeted drug delivery. More than 7,600 physicians, scientists, advanced practice providers, nurses, psychiatrists, psychologists, engineers, pharmacists, advocates, and other professionals from 70 countries attend the conference to share data and learn about the diagnosis, study, prevention, treatment, and cure of epilepsy. The meeting also offered a virtual attendance option, ES 2022 Digital Select, to provide recordings of approximately 120 hours of selected programming and access to ePosters from December 13, 2022, through March 13, 2023 (90 days). See the Meeting Website >
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Meeting Report: 183rd Meeting of Acoustical Society of America (ASA) 2022

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Key Points The 183rd meeting of the Acoustical Society of America took place in Nashville, Tennessee, from December 5–9, 2022. All abstracts are searchable on the meeting planning tool or in the PDF of the open access program. The Foundation thanks Kevin J. Haworth, PhD, Schott Schoen, Jr., PhD, Adam Maxwell, PhD, and Eli Vlaisavljevich, PhD, for assistance in writing this meeting report. The 183rd meeting of the Acoustical Society of America (ASA) took place in Nashville, Tennessee, from December 5–9, 2022. Dozens of abstracts were presented in the field of biomedical acoustics (BA) during the meeting, and joint sessions were held with the physical acoustics (PA), computational acoustics (CA), and signal processing acoustics (PA) technical committees. A broad range of topics were covered, and the material extended from fundamental science investigation to translational bench studies, preclinical studies, and in-human investigations in both imaging and therapeutic ultrasound. The sessions relevant to focused ultrasound are listed below. All abstracts are available in a searchable PDF of the open access program or by using the searchable online meeting planning tool. During the open BA Technical Committee meeting on Wednesday evening, several senior researchers, including Larry Crum, Christy Holland, and Mark Schafer, noted that the content of the meeting was excellent in its scope and depth. The range of invited speakers included great talks from both well-established members of the field and early-career speakers (such as Harriet Lea-Banks of Sunnybrook Research Institute and Dongwoon Hyun from Stanford). The early-career speakers introduced some fascinating new topic areas in ultrasound and provided a refreshing influx of new ideas and concepts. It was a reminder of how bright the future is for this research community and an inspiration for further research. The following presentations were particularly notable: 2aBAb6. “Volatile nanodroplets for neurological applications” (Lea-Banks, Sunnybrook Research Institute) discussed delivery of pentobarbital to specific regions of the brain without disruption of the blood-brain barrier and having specific anesthetic effects to those limited regions. 2pBAb3. “Fibrin-targeted phase shift microbubbles outperform fibrin-targeted microbubbles for the treatment of microvascular obstruction” (Pacella, University of Pittsburgh) discussed results from a series of investigations into the use of nanodroplets plus ultrasound to increase perfusion after acute myocardial infarction. Bench, small animal, and large animal model studies were used with an excellent interplay in how each informed the observations of the others. 3aBA1. “Acoustic droplet vaporization for nonthermal ablation of brain tumors” (Porter, University of Texas at Austin) discussed a series of studies performing mechanical ablation in the rat brain and the improved localization and more thorough treatment when nanodroplets were used as contrast nucleation agents. A special session titled “Detection and quantification of bubble activity in therapeutic ultrasound” was held on Thursday. This session opened with Brian Fowlkes from the University of Michigan providing a summary of the outcomes of the Fall 2021 joint AIUM/FUSF workshop on this topic, as well as current efforts through IEC and other bodies to develop standards. This was followed by presentations in specific areas of cavitation detection and characterization by optical imaging, Doppler, MRI, and passive mapping. A brief panel discussion then outlined considerations for standardizing measurements. Panelists generally agreed that measurements should be guided by application. When possible, it may be valuable to use relative measurements rather than absolute measurement values for the sake of simplicity. Panelists indicated that the technologies to perform at least relative measurements have been well-developed, but the processing and quantities derived from instruments that are specific to each application need further consensus. An afternoon session further highlighted new research areas, including optical and acoustic characterization of histotripsy, tissue permeabilization, biofilm removal, drug delivery, and lithotripsy. New techniques for thermal characterization and computational modeling of microbubble clusters were also presented. During Friday’s 5aBA session, there were several presentations that were relevant to the focused ultrasound community, including abstracts that directly considered focused ultrasound transducers and considerations for characterizing transducer with holography. 5aBA2. “In vivo thermal ablation control using three-dimensional echo decorrelation imaging in swine liver” (Ghahramani, University of Cincinnati) examined the correlation between 3D acoustic correlation images and ablated regions in porcine liver toward controlled ablative treatment. 5aBA3. “The impact of the central opening on nonlinear effects in ultrasound fields generated by Sonalleve V1 and V2 MR-HIFU systems” (V. Khokhlova, University of Washington and Moscow State University) compared the focal patterns and capabilities of the Sonalleve MR-HIFU V1 and V2 systems and described the HIFU-Beam simulation software, which allows time domain nonlinear simulation of annular arrays and layered media. 5aBA4. “Palpating particles using the acoustic radiation force: A new approach to magnetic particle imaging” (Zarcone, Vanderbilt University) proposed using acoustic radiation force to induce motion for magnetic particle imaging. 5aBA5. “Characterizing the steering performance of a diagnostic-therapeutic ultrasound array using measured and synthesized holograms” (Williams, University of Washington and Moscow State University) described the use of holography to characterize the surface of a linear ultrasound array with interleaving measurements to conserve time. 5aBA6. “The use of acoustic holography for simultaneous characterization of various focus steering configurations in ultrasound fields generated by multi-element phased arrays” (V. Khokhlova, University of Washington) performed harmonic and time domain holograms for annular therapeutic focused ultrasound transducers. 5aBA7. “A pipeline to enable large-scale generation of diverse 2D cardiac synthetic ultrasound recordings corresponding to healthy and heart failure virtual patients” (Burman, Katholieke Universiteit Leuven) described the use of augmentation tools for the generation of realistic myocardial velocity profiles toward the generation of large ultrasound training sets for machine learning. 5aBA8. “Contrast-enhanced ultrasound to detect active bleeding” (Schoen, Jr., Harvard Medical School and Massachusetts General Hospital) described methods and in vitro models used to establish the feasibility of microbubbles to assist with the detection of hemorrhage. 5aBA9. “Effect of acoustic output on fetal ultrasound color Doppler performance” (Huber, Duke University) described the setting of as low as reasonably achievable (ALRA) for Doppler ultrasound in neonatal imaging. 5aBA10. “Exploring the benefits of spatial and temporal block-wise filtering architectures” (Weeks, Vanderbilt University) which evaluated the use of spatial and temporal block-wise filtering ...
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Meeting Report: Congress of Neurological Surgeons (CNS) 2022

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Key Points The 2022 Annual Meeting of the Congress of Neurological Surgeons (CNS), “Neurosurgery Connected,” was held October 8–12, 2022, in San Francisco. The conference included discussions of focused ultrasound for movement disorders and for brain and spine tumors. All abstracts are available on the CNS 2022 app. The 2022 Annual Meeting of the Congress of Neurological Surgeons (CNS), “Neurosurgery Connected,” was held October 8–12, 2022, in San Francisco. In one of the Saturday symposia, “Controversies in Movement Disorder Surgery,” Experts debated hot topics within the movement disorder community, including: What is the optimal technique: Deep Brain Stimulation (DBS) vs. High Intensity Focused Ultrasound (HIFU)? The session included case presentations and discussion of complication avoidance or management. Course directors were Sharona Ben-Haim and André Machado, and faculty included Kara Beasley, Casey H. Halpern, Erika A. Petersen, Francisco A. Ponce, Tejas Sankar, and Jason M. Schwalb. A session titled, “Intraprocedural Delivery of Adjuvant Treatments for Brain and Spine Tumors,” included microbubbles plus focused ultrasound. Its description stated, “Tumor surgeons are becoming increasingly involved with delivery of adjuvant treatment during their procedures.” The session highlighted recent advances in intraoperative radiation therapy, microbubble ultrasound, and laser interstitial thermal therapy (LITT) for spinal tumors. The session was moderated by Nancy A. Oberheim Bush and Tiffany R. Hodges. Faculty included Isabelle Germano (intraoperative radiation therapy), Christopher Cifarelli (microbubble ultrasound), Francesco DiMeco (LITT), and Claudio Tatsui (oral abstract presentations). Five abstracts that may be of interest to the focused ultrasound community are listed below. The full text for these abstracts can be accessed by by downloading the CNS app (search “Congress of Neurological Surgeons” and look for the “Neurosurgery Connected” tagline). Cerebral Ischemia165. Intra-arterial Mitochondria as Treatment for Cerebral Ischemia after Thrombectomy by M. Yashar S. Kalani, Pedro Norat, Michael Robert Levitt, Melanie Walker, Jennifer Sokolowski, Petr Tvridk, and Richard Price Thermal Ablation Effects209. What Happens to Brain Outside the Thermal Ablation Zones? An Assessment of Needle-based Therapeutic Ultrasound in Survival Swine by Benjamin Szewczyk, Phillip Johansen, Matthew Tarasek, Zahabiya Campwala, Rachel Trowbridge, Zhanyue Zhao, Zachary T. Olmsted, Chitresh Bhushan, Eric Fiveland, Goutam Ghoushal, Tamas Heffter, Farid Tavakkolmoghaddam, Charles Bales, Yang Wang, Dhruv Kool Rajamani, Katie Gandomi, Christopher Nycz, Erin Jeannotte, Shweta Mane, Julia Nalwalk, Clif Burdette, Gregory S. Fischer, Desmond Yeo, Jiang Qian, and Julie G. Pilitsis Glioblastoma381. Repeated Opening of the Blood-brain Barrier with the Skull-Implantable SonoCloud-9 (SC9) Device: Phase 1 Trial of Nab-paclitaxel and SC9 in Recurrent Glioblastoma by Adam M. Sonabend, Andrew Gould, Yu Luan, Ye Hou, Le Chen, Mikoto Kobayashi, Brandyn Castro, Daniel Zhang, Farida Korobova, Christina Amidei, Mark William Youngblood, John Patrick Bebawy, Benjamin P. Liu, Craig Horbinski, Carole Desseaux, Irene Helenowski, Hui Zhang, Miguel Muzzio, Feng Yue, Michael Canney, and Roger Stupp Essential Tremor853. Voxel-Based Analysis of Lesion and Edema in MR-Guided Focused Ultrasound Thalamotomy for Essential Tremor by Patrick Ng, Alfredo Morales Pinzon, Fardad Behzadi, Michele Cavallari, Andrzej Marciniak, Grégory Bliault, Kezia Irene, Clément Nicolas-Graffard, Sarah Blitz, Melissa Ming Jie Chua, David J. Segar, Bruno Madore, Matthew N. DeSalvo, Thomas Tourdias, Manoj Saranathan, Jason White, Nathan McDannold, Charles R.G. Guttmann, and G. Rees Cosgrove Infiltrating Gliomas874. Direct Visualization of Planned Resection Volumes with Microbubble-Enhanced MR-Guided Focused Ultrasound Blood-Brain Barrier Opening and Sodium Fluorescein in Infiltrating Gliomas by Abdul-Kareem Ahmed, Pavlos Anastasaidis, Dheeraj Gandhi, and Graeme Woodworth To see the full text of all abstracts, download the free CNS App from your app store. See the Meeting Program Book >
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Meeting Report: Radiological Society of North America (RSNA) 2022 Meeting Report: Society of Neuro-Oncology (SNO) Annual Meeting and Education Day Focused Ultrasound for Pancreatic Cancer: Trial Results Prove Safety, Initial Efficacy Clinical Trial of Sonodynamic Therapy for Glioblastoma Begins in Milan Call for Manuscripts: Special Collection on Histotripsy