Amidst a global pandemic that continues to challenge healthcare systems, cancer treatment continues to advance.

Manufacturers have integrated real-time imaging into therapy systems and companies such as IBA, IntraOp Medical and Varian continue to research FLASH therapy, which delivers ultra-high doses of radiation in less than a second.

Here's a glimpse at what's new and on the horizon in both proton therapy and radiation therapy.

PROTON THERAPY

Hitachi Proton
In April, Hitachi Proton’s system was selected in a public bidding process by Tsukuba University in Japan to build their second proton center, which would begin operations in 2025.

In September 2020, Hitachi received Japanese PMDA approval for an imaging device with dual-CBCT functionality and 4D CBCT capability, available for its PROBEAT proton therapy system.

These new technologies will provide faster and more accurate imaging prior to treatment, said Yui Yoshida, manager of the particle therapy division of Hitachi America.

“Dual-CBCT will enable (clinicians) to take CBCT images with only a 110-degree rotation of (the) gantry, which will save time and contribute to faster treatment workflows,” Yoshida said.

Hitachi already has a real-time image gating system during the treatment. And the 4D CBCT imaging technology will further contribute to image quality by reducing motion effects during patient positioning.

IBA
IBA continues to promote, sell, install and maintain its Proteus proton therapy systems to the market. It has sold more than 60 systems worldwide, treating more than 100,000 patients. The next center scheduled to open, in early 2022, for treatment in the U.S. is at University of Kansas Cancer Center.

IBA, its customers and its strategic partners are working together on new clinically relevant technologies.

Among its technology under development is a complete suite of motion management tools to deal with organ motion. The company has several solutions already existing, including beam gating, X-Ray gating and beam repainting. It is currently developing a way to assess interplay effect during the planning phase and a 4D imaging mode that will assess the robustness of the setup before, during or after the treatment delivery.

“Improving the way organ motion is managed should help our customers increase the patients that will qualify for proton therapy,” said Gaelle Coppe, product manager at IBA.

IBA is also developing DynamicARC proton therapy, which delivers spot-scanning proton beam treatments while the gantry is rotating.

“It will be much faster than Intensity-modulated proton therapy and as a result will increase the patient capacity of the treatment room,” said Frederic Genin, president of IBA Proton Therapy North America. “Early research presented by University Medical Center in Groningen showed that head and neck cancers that didn't qualify for proton therapy may now qualify, thanks to proton therapy delivered with DynamicARC.”

The company recently launched a DynamicARC consortium to partner with its key academic accounts to bring the DynamicARC treatment modality to the clinic.

“Our biggest asset is our community of users cumulating more than 250 years of clinical proton therapy experience together,” Genin said.

IBA customers also continue preclinical research on ConformalFLASH therapy, with papers published by researchers from the University of Pennsylvania and other institutions.

“It uses FLASH dose rates as well as the Bragg peak to combine the advantage of both: The conformality and the Flash effect,” said Nicolas Denef, director of emerging therapies at IBA.

Mevion
After a seven-month installation, the Huntsman Cancer Institute in Salt Lake City, Utah, began treating patients with the MEVION S250i Proton Therapy System. Mevion also began installation of the MEVION S250i at Mercy St. Louis and announced the upgrade of the first compact proton system at Barnes-Jewish Hospital to include HYPERSCAN Pencil Beam Scanning and FLASH delivery capabilities.

Mevion is continuing its FLASH proton therapy development, and published a paper on the delivery of FLASH dose rate at any depth with its commercial accelerator, and on the first preclinical results demonstrating the FLASH effect at the Bragg peak. The company believes that FLASH therapy could expand hypofractionated treatments that will further increase utilization and access to proton therapy.

“We are working with our academic partners to explore and demonstrate how to best combine the avoidance benefits of the proton Bragg peak with the FLASH effect, and to do so for all typical cancer indications,” said Townsend Zwart, vice president of advanced development at Mevion.

Mevion is also expanding its global footprint. The first compact proton accelerator was shipped to China at the end of last year, and this year the company joined a multi-institution partnership to establish the first pediatric proton therapy center in China.

Orfit
Last year, Orfit released its Aerial Couch Top for proton therapy. The couch top is attached to a robotic arm, designed to float in the air, so patients can be treated with no obstructions.

“There are no support structures underneath that can get in the way of the beam,” said Emilie Cuypers, product manager for radiation oncology at Orfit.

Aerial can be used with IBA, Mevion and Varian proton therapy systems.

Orfit’s HP PRO thermoplastic mask system, for use in immobilization when treating brain, head and neck cancers, is integrated into Aerial, attaching to an extension of the couch top.

Also in 2020, Orfit released the third generation of its All-in-One patient positioning system, a carbon fiber base plate combined with positioning cushions that index on top of the treatment table for general radiation therapy.

The newly designed AIO Solution 3.0 positions patients using cushions that are made from a comfortable foam. The cushions withstand rough handling conditions, and the integration of handles, clicking instead of screwing materials to fix on the base plate, and lightweight materials make the cushions ergonomic.

ProTom International
The Gordon-Browne Proton Therapy Center at Massachusetts General Hospital has been treating patients with ProTom’s single-room Radiance 330 Proton Therapy System since February 2020. This is a single-room version of the Radiance 330, though ProTom also has the capability to provide multi-treatment room and expandable configurations.

ProTom is also actively pursuing imaging with protons, a technology that will allow improvements in proton treatment planning and implementation, said Stephen Spotts, chief executive officer of ProTom International.

"Radiance 330 is the only proton therapy system that is capable of proton imaging any anatomical location in a patient," Spotts said. "With clinical treatment energy range of 70 MeV to 250 MeV and the ability to accelerate protons up to 330 MeV, the Radiance 330 is capable of treating and imaging with the same beam."

ProTom plans to continue working with its system users, collaborating in the advancement of proton tomography and radiography, Spotts said.

"We will also continue to strive to further reduce the cost of our system, so any radiation oncology practice or hospital can afford an advanced proton therapy system," Spotts said.

While ProTom expands within the U.S. market, the company is also actively developing an overseas market, with customers in Australia and a distribution agreement in place to expand sales of Radiance 330 into China.

The company is moving forward with installation of a Radiance 330 proton therapy system at the new Australian Bragg Centre in Adelaide. This will be the first proton therapy center in Australia and the Southern Hemisphere, and is expected to begin operating in early 2024.

"The Australian government is currently funding 50 patients per year to travel to the U.S. for proton therapy treatment," Spotts said. "A proton therapy center in Australia will make treatment available to many more Australians and New Zealanders, without the need to travel to other countries."

ProTom has also signed a distribution and licensing agreement with Guohong Guokang (Beijing) Health Technology Development Co. Ltd. (GHGK) to distribute the Radiance 330 system in mainland China.

"This cooperation marks that ProTom will closely work with GHGK to actively expand markets in China and the surrounding area," Spotts said. "This signing also signifies the continuing international expansion for ProTom as a significant proton therapy system provider in the worldwide market."

Varian, a Siemens Healthineers Company
Late last year, Varian Medical Systems began treating the first patient in the world with proton FLASH therapy during the start of the first human clinical trial at Cincinnati’s Children’s/UC Health Proton Therapy Center.

As part of the research into the new therapy method, which delivers radiation treatment at ultra-high dose rates, Varian has introduced its FLASH Research Extension (FLEX) Toolkit, allowing facilities to adapt the company's ProBeam proton therapy system into a preclinical FLASH research lab.

The FLEX research solution provides dose monitoring without the need for external systems or readout setups, as the systems aren’t designed to count flash dose rate, said Adam Earwicker, director of market development for FLASH at Varian.

“It’s a new space for Varian,” Earwicker said. “We’re releasing research products in response to the excitement around FLASH research.”

The company plans to release similar tools for its linear accelerators, as well as tools for treatment planning.

RADIATION THERAPY

Accuray
Early this year, Accuray launched ClearRT, helical kVCT imaging on the Radixact system.

The system, which comes with a large, 50-centimeter transverse by 135-centimeter axial field of view, is designed to produce near-diagnostic-quality images at a high speed, cutting the time to produce a typical 3D volumetric image from four minutes to less than 30 seconds, said Corey Lawson, vice president of product strategy at Accuray.

“Because of the clarity of the imaging, clinicians are able to set up their patients much more easily and faster than before, and use those images in adaptive workflows, including dose monitoring and re-planning,” Lawson said.

The image quality was so good, customers had trouble telling the difference between ClearRT helical kVCT and planning images, Lawson said.

Accuray is also planning to introduce VOLO Ultra, a new way of treatment planning on the Radixact radiation therapy system.

The technology, which is 510(k) pending as of press time, accelerates planning and treatment delivery, making it up to 60% faster, according to Lawson. It’s also backward compatible to previous TomoTherapy Systems and can be used across a broad range of cases.

“For users who have never planned for Radixact or TomoTherapy before, it simplifies and automates processes that were previously manual,” Lawson said.

Another new planning technology, RayStation planning for CyberKnife, is another new release that was 510(k) pending as of press time. It takes attributes of RaySearch’s Raystation software and brings them to CyberKnife.

“The goal is really to continue providing our customers with best-in-class options,” Lawson said.

Akesis
In March, Akesis received FDA clearance for its Akesis Galaxy RTi, an advanced gamma stereotactic radiosurgery system for neurosurgery.

The rotating gamma system has real-time, in-line CBCT + kV/kV imaging that allows for mid-treatment position verification.

“This is one of the only dedicated SRS devices where you can image during treatment,” said Tim Prosser, director of global product marketing and management for Akesis. “When doing a mask-based treatment, the system can track the positioning.”

The system also comes with a single drawer with 30 gamma sources, versus other systems with close to 200 individual sources, so when it’s time to replace the Cobalt-60, it takes only a week to change instead of a month, reducing downtime, Prosser said.

“Normally, you place sources all around patient,” Prosser said. “This is in one drawer, and it rotates around patient. It means easier handling from loading to delivery. It’s a good safety innovation because nobody has to handle an individual source.”

Brainlab
This fall, Brainlab will be introducing a Deep Inspiration Breath Hold (DIBH) workflow for ExacTrac Dynamic, the latest version of its ExacTrac Patient Positioning and Monitoring system, which incorporates surface, thermal and x-ray monitoring at any couch position.

“This new technology will go beyond surface tracking alone to allow a combination of surface, thermal, and X-Ray monitoring of the internal anatomy at the breath-hold level,” said Patrick Murphy, director of the oncology portfolio at Brainlab. “We will provide more reassurance to the user that they’re avoiding critical structures like the heart.”

Last year, the company brought the latest versions of Multiple Brain Mets SRS, Elements Cranial SRS and Elements Spine SRS to 250 customers worldwide.

Each software solution was updated with preplanning features, including Anatomical Mapping, which registers data sets to a synthetic full-body tissue model and adapts to the image modality for a more consistent and accurate segmentation; SmartBrush, which outlines cranial tumors with partial automation on multiple modalities, minimizing variability when compared to manual outlining; and Image Fusion Angio and SmartBrush Angio, which provide frameless co-registration of multiple 2D digital subtraction angiography (DSA) image pairs and angiographic 3D CT, MR and DSA image data, presents color representation of contrast flow in order to visualize temporal changes in cerebrovascular structures, and fuses and outlines intracranial vascular structures with a combination of 2D and 3D imaging data.

The company has been holding webinars at novalis-circle.org in which Brainlab customers highlight how they’re using the Elements automated software workflows together with ExacTrac Dynamic.

“Novalis Circle provides a community for our customers to share best practices and exchange knowledge to advance precision radiotherapy,” Murphy said. “Especially now, as many users are not able to join in-person meetings, live webinars provide a platform for open discussion in a remote setting.”

In 2020, Brainlab purchased Mint Medical, which provides structured reporting of radiology reads. Brainlab plans to integrate its anatomical mapping technology into the Mint software to “create an ecosystem that allows seamless flow of patient data from radiology to tumor boards, to treatment planning and follow-up,” Murphy said.

“This acquisition allows us to structure data at the start of the patient journey, front-loading the treatment planning process with more detailed and clinically relevant information,” Murphy said. “During tumor board meetings, participants will gain access to standardized reports on radiological findings to support their patient-specific treatment discussions and decisions.”

“In addition to improvements in routine clinical workflows, the combination of Brainlab and Mint Medical will improve the technological infrastructure for managing clinical trials, as well as large-scale registries and quality assurance,” Murphy said. Post treatment, integrating data from oncology and radiology will enhance the follow-up process through a systematic response assessment and patient-reported outcome measures with Visiontree.

Elekta
In September 2020, Elekta introduced its latest linear accelerator, Elekta Harmony. The device was CE marked in November 2020 and FDA 510(k) cleared in June of this year.

“Harmony was designed to simplify and streamline the radiotherapy process, with guided workflows and a user interface that facilitates a short learning curve,” said Gregory Trausch, senior vice president and head of global marketing and commercial excellence at Elekta. “The interface gives the treatment staff all the information they need where they need it. The results are shorter treatment times, greater productivity and more patients treated.

“The system is an answer to a need we see in the marketplace,” Trausch said.

In January, the company received FDA clearance for Elekta Studio, a single room treatment system for interventional radiotherapy, such as brachytherapy. The core component of Elekta Studio is an interventional CT system called ImagingRing that provides imaging information at the time of treatment, and is also mobile and can be moved around the hospital.

The company also released MOSAIQ 3, the third generation of its oncology informatics solution. The new version is focused on increasing automation, with a more simplified user interface and a new 2D Image Review Workspace with what Trausch said is better image registration, for faster image review and approval.

GT Medical Technologies
GT Medical Technologies first received FDA clearance in 2018 for its GammaTile Therapy technology, in which recurrent brain tumors are treated with small radioactive squares implanted during surgery.

In early 2020, the FDA expanded its clearance to include newly-diagnosed malignant brain tumors.

Matthew Likens, president and chief executive officer of GT Medical Technologies, said the technology eliminates the need to wait several weeks after neurosurgery for radiation therapy to start and allows the patient to undergo treatment without trips to and from the hospital.

GammaTile Therapy is now offered at 44 institutions around the country, including Memorial Sloan Kettering and MD Anderson cancer centers.

"GammaTile is the first advancement in brain tumor treatment in a decade,” Likens said. “GammaTile improves outcomes and patient quality of life, which has led to accelerated adoption at top brain tumor centers in the U.S."

IntraOp Medical
Earlier this year, IntraOp Medical announced an enhanced version of its Mobetron to treat cutaneous lesions like skin cancer with noninvasive electron therapy.

The device has an extended gantry range and quick-connect collimator system to better access the patient and can cut treatment from 20 minutes to seven to eight minutes.

“We saw an opportunity to optimize the system and make electron treatments convenient and more accessible for these patients,” said Derek DeScioli, chief executive officer of IntraOp Medical.

The first two systems have been installed in the U.S. The company also expanded its Prelude software to manage skin cancer patients.

In July, the company announced a preclinical phase I trial of FLASH radiotherapy in patients with skin metastases from melanoma at Lausanne University Hospital in Switzerland. The Mobetron platform was enhanced to deliver ultra-high dose rates with electrons.

The company expects that two other clinical partners will be opening investigative trials next year.

Leo Cancer Care
Leo Cancer Care offers a radiotherapy treatment system with positioning that allows treatment to be delivered in a seated position with rotation of the patient, instead of the heavy equipment, along with dual-energy CT.

Stephen Towe, the chief executive officer of Leo Cancer Care, co-founded by medical physicist Thomas “Rock” Mackie, says the seated position allows for less organ movement and ensures the lungs are more inflated.

“We've really turned this on its head and reduced the size, cost and complexity of radiation therapy,” Towe said.

Earlier this year, the company installed its first particle therapy-compatible system, called Marie, in Europe. The system includes the patient positioning device and a dual-energy multi-access fan beam CT scanner.

“Particle therapy is delivered mostly in larger centers,” Towe said. “The Leo Cancer Care system brings the cost down so dramatically you can really use the phrase ‘democratizing particle therapy’.”

Photon therapy systems are currently in development.

RefleXion Medical
The RefleXion X1, which combines fan-beam CT with a linear accelerator, was FDA cleared March 2020 to provide stereotactic body radiation therapy (SBRT), stereotactic radiosurgery (SRS) and intensity-modulated radiation therapy (IMRT).

The company is pursuing FDA approval for biology-guided radiotherapy (BgRT) using PET and CT imaging with the system, which offers the “promise of tumors being biological beacons,” said Sam Mazin, RefleXion Medical’s founder and chief technology officer.

BgRT using the X1 is being studied clinically by the Stanford Cancer Institute and University of Texas Southwestern in Dallas under an investigational device exemption, looking at BgRT feasibility and workflow to gain FDA approval, possibly under the De Novo pathway.

“We’re happy to be viewed by the federal government as new, which could have other benefits down the road,” Mazin said.

Stanford and the City of Hope cancer center in California already use the X1 for image-guided radiotherapy using CT.

“We hope that BgRT will one day provide metastatic disease patients with more treatment options than they have today. Studies in patients with limited metastatic disease are showing that just adding conventional radiotherapy provides not just months of benefit, but one to two years of benefit for Stage 4 cancers,” Mazin said.

Also last year, RefleXion announced a clinical collaboration to evaluate BgRT with Merck's KEYTRUDA for certain late-stage cancers.

“We believe that this is a sign that combination therapy is the next frontier,” Mazin said.

Pyrexar
Pyrexar is awaiting installation of its BSD-2000 3D/MR, an MR-guided hyperthermia system, in Turkey and Taiwan.

The system, used in conjunction with radiotherapy for recurrent cancers, delivers RF energy waves to the tumor, with MR imaging providing information on heat volume.

The base unit (BSD-2000) without MR guidance is currently FDA cleared for cervical cancer with a humanitarian device exemption, said Mark Falkowski, chief executive officer at Pyrexar.

TeamBest Companies
In 2021, Best Cyclotron Systems, a member of Team Best Global, released a number of new cyclotrons, including a B35adp alpha/deuteron/proton cyclotron; a B3d low energy proton/deuteron cyclotron; a 100 MeV variable energy cyclotron proton therapy system; a 15 to 35 MeV variable energy, high-current proton cyclotron; and a 6–15 MeV compact, high-current, variable-energy proton cyclotron.

Best Cyclotron Systems also announced an upgrade of its Best 35–70 MeV proton cyclotron to 1000 µA, while Best ABT, a TeamBest Global company, introduced the Best Sub-Compact Model 200 self-shielded cyclotron for radioisotopes.

TeamBest Global Companies also won an international tender for a 6 MeV high-current proton cyclotron, which the company says is the first cyclotron of its kind in the world.

Krishnan Suthanthiran, president of TeamBest, said the company is willing to partner with cancer centers to help them operate and service their cyclotrons.

"These technologies are highly complex and need to be expertly operated," Suthanthiran said.

Xoft
Xoft, a subsidiary of iCAD Inc., is expanding use of its electronic brachytherapy device into new therapeutic areas. It’s currently used for the treatment of early-stage breast cancer, nonmelanoma skin cancers and gynecological cancers, although it is FDA cleared, CE marked and licensed in a growing number of countries for the treatment of cancer anywhere in the body. The company recently developed a new applicator for rectal cancer and there is currently a trial underway to evaluate the use of Xoft for the treatment of rectal tumors.

The company is also expanding use of the Xoft System for the treatment of various types of brain tumors, such as recurrent glioblastoma multiforme. An ongoing study in Russia has been comparing patients who received a craniotomy and traditional treatment to patients who have undergone surgery and intraoperative radiation therapy with the Xoft technology.

“Patients in the external beam control group lived up to two years, whereas survival in the IORT group ranged up to four and a half years after treatment,” said Stacey Stevens, president of iCAD. “This research is extremely promising and demonstrates the Xoft System’s versatility as a viable treatment option for various types of tumors.”

The company hopes to replicate the results in a study of 80 to 100 patients. There are also plans to expand use of the Xoft System to prostate cancer treatment in the future.

ZAP Surgical
Over the past year, ZAP Surgical has received CE marking and Shonin approval from the Japanese Pharmaceuticals and Medical Devices Agency for its ZAP-X Gyroscopic Radiosurgery Platform, the first and only vault-free and cobalt-free dedicated cranial stereotactic radiosurgery (SRS) system.

The system, FDA cleared in 2017, eliminates the high costs of building shielded radiation treatment rooms and the costs to license, secure and regularly replace live radioactive isotopes, said Mark Arnold, senior vice president of marketing for ZAP Surgical.

While estimates indicate there are more than two million potential SRS patient candidates each year, only 150,000 are treated due to the significant costs and complexities of historical delivery technologies, according to Arnold.

“Our goal is to bring world-class SRS to the two million-plus patients a year who currently lack access,” Arnold said.

The device was invented by Dr. John R. Adler, Stanford neurosurgeon, inventor of the CyberKnife and former chief medical officer of Varian Medical Systems. The device includes a dual-gantry design and uses gyroscopic mobility to direct radiation beams from hundreds of unique angles to concentrate radiation to the tumor target while helping to spare surrounding healthy brain tissue.

“There is greater solid-angle beam coverage as ZAP-X is not limited by the clockwise and counterclockwise rotations commonplace with multipurpose radiation delivery platforms,” Arnold said.

To date, there are seven systems in clinical use and more than 25 sites around the world at varied stages of site planning and installation, spanning large academic institutions, small community hospitals, free-standing clinics and even small outpatient surgical centers.

“We’re seeing uptake that has well exceeded expectations,” Arnold said. “We scaled our 2020 targets back due to COVID, but ended 2020 exceeding pre-pandemic goals.”