Investing in Clinical Research to Improve Patient Outcomes | Varian

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Investing in Clinical Research to Improve Patient Outcomes

Investing in Clinical Research to Improve Patient Outcomes

Centerline

As an integral part of Siemens Healthineers, Varian works to pioneer breakthroughs in healthcare. We know that clinical research is an essential part of developing the evidence that will drive advances in the standard of care by enabling the most personalized, effective treatment approaches possible.

Varian is committed to investing in research that supports the development of newer treatment technologies and advancements, with the hope of bringing needed therapies to more patients across the globe. Our goal is to give clinicians the power to make more informed decisions so they can deliver the right care at the right time to improve outcomes.

“For Varian, this means supporting research that establishes the value of our innovations in improving patient outcomes and quality of life, and whenever possible, improving survivorship,” said Dr. Ricky Sharma, Vice President Clinical Affairs at Varian. “Just as important, we seek to ensure that our technologies and services make it easier for clinical teams to deliver the most advanced standards of care, everywhere in the world.”

Working collaboratively with cancer care teams, research institutions, patient advocacy groups, and professional medical societies across the globe, Varian is investing in projects that are designed to contribute to the body of knowledge about cancer treatment as well as other treatment areas where targeted radiation can make a difference.

Through sponsored trials and investigator-initiated studies, Varian is supporting over 100 clinical studies, generating evidence across many topics and treatment areas, as outlined below.

Varian’s Current Clinical Research Project Portfolio

Recently, Varian has focused the lion’s share of its research support for projects in five main areas: Adaptive Radiotherapy, Advanced Imaging in the Radiotherapy Treatment Process, Interventional Radiology, Proton FLASH Therapy, and Cardiac Radioablation. Other, smaller focus areas include such topics as: stereotactic body radiotherapy (SBRT), proton therapy, MR-guided boost, treatment planning, dual-energy CT, hypofractionated dose escalation, pelvic bone sparing RT, the use of embolics to treat osteoarthritis of the knee, and AI-based detection of treatment errors.

Adaptive Radiotherapy

Varian’s Ethos adaptive radiotherapy system is an AI-driven solution that enables treatment teams to plan and deliver adaptive treatments.

Varian is supporting a portfolio of adaptive trials, including the Varian-sponsored ARTIA clinical research program (Adaptive Radiation Therapy using an Individualized Approach). To date, some 20+ institutions are participating in more than 30 studies, covering some 16 disease sites.

Early reports from clinical researchers appear to support the idea that the use of Ethos adaptive therapy, by enabling more accurate tumor targeting daily, can result in a reduction in acute toxicities. For example, in the DARTBOARD study at the University of Texas Southwestern Medical Center, daily adaptive radiotherapy with Ethos allowed the use of very narrow margins around targets for patients with head & neck cancer (1-2 mm). Compared to patients treated with standard margins (5 mm) there was significantly less high-grade acute dermatitis and significantly less patient-reported sticky saliva at 6 months.1

At the recent European Society for Radiotherapy and Oncology Congress (ESTRO 2024), activities centering on Varian’s Ethos adaptive radiotherapy technology included two oral presentations2,3 and some 50 abstracts encompassing digital, mini-oral, and poster discussion sessions. Of those, four—two poster discussions and two digital posters—reported encouraging early clinical outcomes in breast, cervical, and head & neck cancer.4,5,6,7 (The rest covered topics like dosimetry, RTT workflow, feasibility of adaptive workflows, and other important themes not directly related to patient outcomes).

Advanced Imaging in the Radiotherapy Treatment Process

In 2022, Varian introduced the optional HyperSight imaging solution for its Halcyon and Ethos radiotherapy systems. Earlier this year, HyperSight became available for use on TrueBeam and Edge systems as well. HyperSight allows clinicians to acquire high-quality cone-beam CT (CBCT) images with Hounsfield Unit (HU) accuracy, so that the images can be used for online and offline adaptive treatment planning. The enhanced image quality is designed to improve the ability to target tumor volumes more precisely and spare healthy tissue for patients receiving radiation therapy treatments, with the goal of improving patient outcomes.

Recent research on HyperSight presented at the recent ESTRO Congress shows that image quality8,9 and utility for treatment planning10 are superior to what was possible using earlier generations of in-room CBCT imaging technology, except where breathing motion introduces artifacts that hamper accurate dose calculation. In addition, online adaptive radiotherapy is feasible as seen in stage II-III rectal cancer patients, without the need for generating a separate planning CT, enabling a reduction in time to treatment.11

Interventional Radiology

Varian is supporting studies relating to interventional radiology in two areas: the use of microwave ablation as a treatment for metastatic colorectal cancer, and the use of genicular artery embolization to treat symptomatic knee osteoarthritis.

Image-Guided Microwave Ablation for the Treatment of Metastatic Colorectal Cancer
Over the past decade or so, evidence has accrued to suggest that image-guided microwave ablation is a viable approach to treating metastatic colorectal cancer.12,13 Nevertheless, surgical resection remains the standard of care in treatment guidelines and tumor board reviews don’t always include an interventional radiologist.

To support the additional in-depth research needed to truly evaluate image-guided microwave ablation as a treatment for metastatic colorectal cancer, Varian joined with other industry partners to support a clinical trial under the auspices of the Society of Interventional Oncology (SIO), "Ablation with Confirmation of Colorectal Liver Metastases (ACCLAIM) Prospective Trial for Microwave Ablation as a Local Cure."

The ACCLAIM trial, SIO’s first, is “the first global, prospective trial to use an objective and reproducible technical outcome in its study design, which SIO believes will drive important changes to future treatment guidelines,” according to the SIO press release announcing the launch of the study.

Genicular Artery Embolization for Symptomatic Knee Osteoarthritis: Genesis II and GRAVITY
Genicular artery embolization (GAE) is an investigational treatment for knee osteoarthritis, an extremely common, painful, and debilitating condition that’s also one of the leading causes of disability. In a GAE procedure, a small catheter is advanced into one or more of the arteries supplying the knee joint known as the genicular arteries. Embolic microspheres are delivered through the catheter to reduce the blood supply to the vessels, which may decrease inflammation.14

Varian is among those supporting two studies of GAE for the treatment of knee osteoarthritis (OA). GENESIS II, based in the UK, is a double-blind, sham-controlled, randomized trial investigating the use of a permanent embolic agent for embolization of abnormal genicular arterial vasculature to reduce pain in patients with mild to moderate knee osteoarthritis.

Varian is also providing support for GRAVITY, a prospective, randomized open-label U.S. Food and Drug Administration-approved investigational device exemption study being conducted at UCLA. This trial seeks to compare clinical outcomes of GAE and observation, as well as to identify biomarkers and imaging endpoints for this emerging therapy.

“At Varian, we believe that new, innovative, and minimally invasive treatment options that support patients in their activities of daily living can have tremendous overall impact on patient lives,” says David Hahn, chief medical officer for Varian’s Interventional Solutions business. “We are excited about addressing the important scientific questions on the role of GAE in treating knee OA as part of our commitment to developing meaningful clinical data within the field of interventional radiology and look forward to seeing the results.”

Proton FLASH Therapy – FAST-01 and FAST-02

Varian received Investigational Device Exemption (IDE) approval from the Food and Drug Administration (FDA) for two clinical trials of FLASH therapy, an experimental treatment modality that involves delivering therapeutic doses of radiation very quickly—in just a fraction of a second. In the first study, FAST-01 (FeAsibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases), concluded in 2023, the technology for proton FLASH radiation treatment was shown to be as safe and appeared to be as effective as conventional radiation without causing unexpected side effects.15 These findings led to a new IDE for FAST-02, launched in February 2023, which builds on the clinical evidence from FAST-01 and will include the treatment of bone metastases in the chest, providing critical insights into potential of FLASH treatment for cancer metastases.

Cardiac Radioablation

Last year, the U.S. Food and Drug Administration (FDA) approved an IDE for a pivotal RADIATE-VT clinical trial, sponsored by Varian. This is the first international, multi-center, randomized controlled trial to evaluate the safety and efficacy of Varian’s cardiac radioablation (CRA) system compared to repeat catheter ablation for patients with high-risk refractory ventricular tachycardia (VT).

RADIATE-VT is open and enrolling, and will enroll 380 participants across 20+ institutions. Please note that Varian’s CRA system is an Investigational Device, limited by United States law to investigational use.

"Varian has long been a leader in radiotherapy innovation, and through this trial we're looking at the viability of expanding the application of our technology for a new patient population,” said Deepak "Dee" Khuntia, M.D., Senior Vice President and Chief Medical Officer at Varian. “We are eager to see this solution evaluated in the clinical trial setting at leading institutions around the world, which also would support future submissions for regulatory marketing authorization.”

Study outcomes described in this article encompass “post-market” studies of labeled uses (e.g., the ARTIA studies) and investigational research into new uses (e.g., GAE, the FAST studies, and CRA). As results may be preliminary, we recommend you review the actual study reports for more detail as your results may vary.

References

  1. Sher DJ, Avkshtol V, Lin MH et al. Acute Toxicity and Efficiency Outcomes in the DARTBOARD Randomized Trial of Daily Adaptive Radiotherapy for Head and Neck Squamous Cell Carcinoma. Int J Radiat Oncol Biol Phys. 2023;117(4):e6.
  2. Koen J Nelissen, Eva Versteijne, Suresh Senan, et al. Clinical experience with same-day delivery of adaptive palliative radiotherapy without a planning CT.
  3. Karin Goudschaal, Sana Azzarouali, Jorrit Visser, et al. Support system in an RTT-only Conebeam CT-guided online adaptive radiotherapy workflow.
  4. Angelique R.W. van Vlaenderen, Koen J. Nelissen, Judith G. Middelburg-van Rijn et al. CBCT-guided online adaptive radiotherapy in breast cancer patients – a prospective trial. NL2021.0624
  5. Ajcharee Nuengsigkapian, Petch Alisanant, Kanokphorn Thonglert, et al. AI-enhanced Adaptive Intensity Modulated radiotherapy for Cervical cancer (AIM-C): Early experience.
  6. Philip Blumenfeld, Eduard Arbit, Robert Den, et al. Daily artificial intelligence-assisted online adaptive radiotherapy for head and neck cancer.
  7. Sridhar Papaiah Susheela, Anuradha Pinninti, Priyasha Damodara, et al. Early response assessment of Ca cervix treated with PETCT based SIB-Online Adaptive Radiotherapy.
  8. Britt Kunnen, Agustinus J.A.J. van de Schoot, Kimm P. Fremeijer, et al. Ethos HyperSight: what is the added value compared to conventional ring gantry cone-beam CT.
  9. Nienke D. Sijtsema, Joan J. Penninkhof, Agustinus J.A.J. van de Schoot, et al. HyperSight CBCT directly suitable for offline adaptive radiotherapy for prostate, but not for lung.
  10. Vicki T Taasti, Colien Hazelaar, Marta Bogowicz, et al. Clinical evaluation of CT number stability of advanced cone-beam CT for thorax and pelvic patients.
  11. Claudia S.E.W. Schuurhuizen, Judith H. Sluijter, Pim J.J. Damen, et al. Online adaptive radiotherapy without planning CT scan: a prospective clinical trial in rectal cancer.
  12. Takahashi, H., & Berber, E. (2019). Role of thermal ablation in the management of colorectal liver metastasis. Hepatobiliary Surgery and Nutrition, 9(1), 49-58.
  13. Meijerink MR, Puijk RS, van Tilborg A, et al. Radiofrequency and Microwave Ablation Compared to Systemic Chemotherapy and to Partial Hepatectomy in the Treatment of Colorectal Liver Metastases: A Systematic Review and Meta-Analysis. Cardiovasc Intervent Radiol 2018;41:1189-204.
  14. Padia SA, Genshaft S, Blumstein G et al. Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis. JB JS Open Access. 2021 Oct 21;6(4):e21.00085. doi: 10.2106/JBJS.OA.21.00085. PMID: 34703964; PMCID: PMC8542160.
  15. FLASH radiation therapy shows promise in first-in-human trial - American Society for Radiation Oncology (ASTRO). Accessed May 7, 2024.