Breaking News
March 24, 2018 - Men have greater hospital readmission risk following firearm injury, study shows
March 24, 2018 - Pediatric psychologist shares 11 warning signs of childhood depression
March 24, 2018 - OncoBreak: ‘I Was Normal Once’; Ending Cervical Cancer; Mammo Controversy
March 24, 2018 - Gum Disease by the Numbers
March 24, 2018 - Studies show tool can identify individual needs, supports to help youths with autism, intellectual disabilities
March 24, 2018 - Study reveals cause of extreme nausea in pregnancy
March 24, 2018 - New findings highlight need to reconsider cervical cancer screening guidelines
March 24, 2018 - Smartwatch App Might Help Detect A-Fib
March 24, 2018 - TAVR Reasonable for Low-Flow, Low-Gradient Aortic Stenosis
March 24, 2018 - Kids with severe brain injuries may develop ADHD: study
March 24, 2018 - Researchers explore ways to help older adults taper off and stop using sedatives
March 24, 2018 - Back pain being mismanaged globally
March 24, 2018 - Fingerprint test accurately and noninvasively detects heroin, cocaine users
March 24, 2018 - Leading experts to promote cardiovascular health at EuroPrevent 2018
March 24, 2018 - A Role for Rituximab in Lupus?
March 24, 2018 - New osteoarthritis genes discovered
March 24, 2018 - Maternal intake of DHA supplement linked to higher fat-free body mass in children
March 24, 2018 - Royal College of Pathologists‘ bulletin provides summary of Tissue Handling Workshop
March 24, 2018 - Maternal alcohol use early in pregnancy may be risk factor for infant abdominal malformation
March 24, 2018 - Savara Initiates Phase 2a Clinical Study of Molgradex for the Treatment of NTM Lung Infection
March 24, 2018 - Accelerated WBI Should be the Norm for Most Breast Cancers
March 24, 2018 - Experts seek to standardize treatments for childhood rheumatic diseases
March 24, 2018 - Foil-based measuring chip rapidly detects Legionella
March 24, 2018 - Bariatric surgery linked to positive outcomes in very obese adolescents with type 2 diabetes
March 24, 2018 - Are there risks from secondhand marijuana smoke? Early science says yes.
March 24, 2018 - NUST MISIS researchers produce elastic metal rods for scoliosis treatment
March 24, 2018 - New University of Bath project seeks to make injections safer
March 24, 2018 - Higher-dose RT does not improve survival but reduces recurrence risk for prostate cancer patients
March 24, 2018 - Researchers examine link between knee pain and depression in older adults
March 24, 2018 - FDA Alert: BD Vacutainer Blood Collection Tubes by Becton, Dickinson and Company (BD): Class I Recall
March 24, 2018 - Daytime Sleepiness Linked to Amyloid Accumulation Without Dementia
March 24, 2018 - Energy storehouses in the brain may be source of Alzheimer’s, targets of new therapy
March 24, 2018 - Praising people with autism shows promise for producing more exercise
March 24, 2018 - Using harmless red or infrared light to diagnose breast cancer
March 24, 2018 - Clash over abortion hobbles a health bill. Again. Here’s how.
March 23, 2018 - Virtual nature environment could be new way to recover from stress
March 23, 2018 - New study identifies key cellular mechanisms behind vascular aging in mice
March 23, 2018 - Nightmares Common Among U.S. Troops, But Seldom Reported
March 23, 2018 - Another Record Low for Tuberculosis in U.S.
March 23, 2018 - Changes in the eye connected to a decline in memory
March 23, 2018 - Radiologist creates dramatic teaching tool using power of VR
March 23, 2018 - Grilled meat could be raising the risk of hypertension finds study
March 23, 2018 - Mutations found in bassoon gene may help explain cause of rare brain disorder
March 23, 2018 - Childhood Brain Injuries May be Linked to ADHD Years Later
March 23, 2018 - Why treating addiction with medication should be carefully considered
March 23, 2018 - Researchers make key discovery about cellular pathway linked to myriad of diseases
March 23, 2018 - Researchers uncover cause of rare childhood neurodegenerative disease
March 23, 2018 - Measles infection in early childhood could contribute to later COPD
March 23, 2018 - Opioid painkiller is top prescription in 11 states
March 23, 2018 - Sienna Biopharmaceuticals Announces First Patient Dosed In Proof-of-Concept Trial of Topical By Design™ JAK Inhibitor SNA-125 for Atopic Dermatitis
March 23, 2018 - In Teen Girls, Neural Patterns May Drive Emotional Resilience
March 23, 2018 - Gene-based test for urine detects, monitors bladder cancer
March 23, 2018 - BD to introduce new digital solution for IV chemotherapy administration process at EAHP 2018
March 23, 2018 - New computational method helps to identify tumor cell mutations with greater accuracy
March 23, 2018 - Researchers identify potential obesity treatment in freezing hunger-signaling nerve
March 23, 2018 - Wales participates in the 100,000 Genomes Project
March 23, 2018 - 24-Hr Paging Cuts ED Visits for Kids with Endocrine Issues
March 23, 2018 - The brain learns completely differently than we’ve assumed since the 20th century
March 23, 2018 - Less nutritious diet mainly contributes to Type 2 diabetes among U.S.-based South Asians
March 23, 2018 - Stony Brook Medicine expert provides tips for healthy diet to decrease cancer risk
March 23, 2018 - New findings could have revolutionary impact on quality of life of older people
March 23, 2018 - Restoring enzyme may help reverse effects of vascular aging, study shows
March 23, 2018 - Protein profiling reveals new prostate cancer mechanisms
March 23, 2018 - Depression may be linked to increased risk of atrial fibrillation
March 23, 2018 - FDA Takes Aim at Flavored Tobacco
March 23, 2018 - SMART Strategy Lowers Asthma Exacerbation Risk
March 23, 2018 - Cold open water plunge provides instant pain relief
March 23, 2018 - Portable and wearable technology supports future of military medical devices
March 23, 2018 - Patients with vascular malformations have poor health-related quality of life
March 23, 2018 - Researchers develop unique technology to overcome global antibiotic resistance crisis
March 23, 2018 - New DOD grant to support testing of promising therapy for triple-negative breast cancer
March 23, 2018 - Novel vaccine technologies can help better prepare for future infectious disease threats
March 23, 2018 - OncoBreak: Colonoscopy TV; Coverage for Genomic Testing; Care for Caregivers
March 23, 2018 - For some surgeries, nerve blocks mean better outcomes, fewer opioids
March 23, 2018 - Maternal obesity and androgen excess induce sex-specific anxiety in offspring, study suggests
March 23, 2018 - The tale of Theranos and the mysterious fire alarm
March 23, 2018 - USC researchers create algorithm to optimize substance abuse intervention groups
March 23, 2018 - Impulsivity may be associated with greater weight loss during treatment in obese children
March 23, 2018 - CTI BioPharma Announces Publication of Pacritinib Phase 3 PERSIST-2 Clinical Trial in JAMA Oncology
March 23, 2018 - Senate Panel Addresses Native Americans’ Opioid Troubles
Hitachi gets FDA clearance for commercialization of Real Time Image Gating System for Proton Beam Therapy Systems

Hitachi gets FDA clearance for commercialization of Real Time Image Gating System for Proton Beam Therapy Systems

image_pdfDownload PDFimage_print

Hitachi, Ltd. and Hokkaido University announced that it has obtained U.S. Food & Drug Administration (FDA) 510(k) clearance on December 26, 2017 for the commercialization of “Real Time Image Gating System for Proton Beam Therapy Systems” (RGPT), allowing for its systems in the United States to treat patients with cutting-edge motion management together with its advanced Spot Scanning irradiation technology.

Proton therapy is a type of radiation used to treat cancer in which protons from a hydrogen atom are extracted and accelerated up to 60% the speed of light. Its energy is concentrated directly on the tumor while avoiding radiation dose to the surrounding healthy tissues. Patients experience no pain during treatment and the procedure has very few side effects compared with that of traditional radiotherapy. In most cases, patients can continue with their normal daily activities while undergoing treatment, thus maintaining their Quality of Life. For these reasons, demand for this type of cutting-edge irradiation therapy continues to grow around the world.

In 2010, a grant under the Funding Program for World-Leading Innovative R&D on Science and Technology (the “FIRST Program”) sponsored by the Japanese government was awarded to the project between Hitachi and Hokkaido University to jointly develop an advanced technology to treat moving targets with proton beam therapy. By 2014, RGPT and the advanced irradiation technology of Spot Scanning were integrated into Hitachi’s system for the first time. Conventional motion management simply tracks the surface of the patient’s body and irradiates with the proton beam based on a predetermined timing. By tracking the location of gold markers placed near the tumor with X-rays, RGPT is able to irradiate the targeted tumor while in motion and with greater accuracy with a proton beam.

Hitachi received clearance from Japan’s Pharmaceuticals Medical Device Administration for its Proton Beam Therapy system equipped with RGPT (patent no. 05896211) in August 2014. Jointly developed with Hokkaido University Hospital (Dr. Kiyohiro Houkin, Director) and its Clinical Research and Medical Innovation Center (Dr. Norihiro Sato, General Manager), RGPT has been used in approximately 70% of patients treated in the past 3 (approx.) years at the hospital. RGPT has since been highly acclaimed and has been awarded the Imperial Invention Prize of 2017 – an honor bestowed by the Japan Institute of Invention and Innovation for the most outstanding inventions.

Dr. Hiroki Shirato, Director of Hokkaido University Hospital’s Research Group with which Hitachi conducted the joint development, stated, “Hokkaido University has been developing motion tracking technology in the field of X-ray therapy. By combining this technology with Spot Scanning technology, the accurate irradiation of tumors, including those attached to large organs in motion which are difficult to irradiate with X-rays, will be possible and will lead to greater adaptation. I am very pleased that this innovation for highly precise irradiation will become broadly available around the world.”

With this FDA clearance, Hitachi will move forward with plans to install RGPT at facilities under construction in the United States.

Hitachi provides superior proton therapy systems to world-class hospitals in Japan, the United States and around the world. With more than 16,000 patients treated with its systems, Hitachi has earned a reputation for high reliability and achievements. With its cutting-edge R&D, Hitachi will focus on the growing global demand for single room treatment facilities within the expanding market.

Hitachi and Hokkaido University will continue to accelerate innovation in particle therapy in order to contribute to cancer treatment around the world.

Overview of Real Time Image Gating System for Proton Beam Therapy Systems (RGPT)

Real Time Image Gating Proton Beam Therapy is a technology used to track and irradiate tumors in motion. This is accomplished by positioning a gold marker 2mm in diameter, close to the tumor and establishing its location as a reference via CT. A dual-axis, orthogonal X-ray system is used with pattern recognition software to determine the spatial location of the marker due to respiration. Irradiation during treatment is performed only when the gold marker moves to within millimeters of the planned irradiation location. This process, when repeated, can be synchronized to the respiratory motion of the patient. As a result, the harmful impact of irradiation to healthy tissue can be significantly reduced.

Overview of Spot Scanning Technology

Spot Scanning irradiation technology does not scatter proton beams as with conventional proton beam therapy. Rather, it repeatedly turns a narrow proton beam on and off at high speed as it progressively changes location to irradiate entire tumor volumes. Protons can be aimed with high precision according to the targeted tumors, even those with complex shapes, while minimizing the impact on nearby healthy tissue.​


Hitachi Receives FDA 510(k) Clearance for Real Time Image Gating Motion Management for its Proton Therapy System

Tagged with:

About author

Related Articles