As patients live longer, thanks to improved cancer therapies, radiosurgery is no longer just a precise treatment, but it has become a long-term responsibility. Naren Ramakrishna, MD, PhD, Director of Proton Therapy and Neuro/Pediatric Radiation Oncology at Orlando Health Cancer Institute, spoke with us about that responsibility and how the Novalis Certified Program helps ensure radiosurgery is delivered with the highest quality and care.

Beyond the Lab: Dr. Ramakrishna, you've been treating brain metastases for a long time. Has your perspective on that changed over the years?
Naren Ramakrishna: Yes, quite a bit. When I first started, brain metastases were usually treated as an endstage diagnosis. The median survival was often just six to eight months. Back then, treatment was more uniform, consisting mainly of surgery and whole-brain radiation. Radiosurgery was relatively rare, and we didn’t have the systemic therapies we have today. Now, prognosis and treatment paradigms have evolved to be disease-specific. Depending on the tumor type, patients can live for many years. That changes everything. It raises the stakes for how we treat the brain, because long-term cognitive function and quality of life become just as important as survival.

Forgive the naive question – but if these new therapies you mentioned are effective, why do brain metastases actually still occur?
Many of the treatments we now use systemically—like immunotherapy—work incredibly well in the body, but not as well in the brain. So we see patients whose primary tumor can be treated well, but who repeatedly develop new brain metastases simply because they now live for a long time despite their cancer potentially increasing their cumulative risk of brain failure. That’s where radiosurgery becomes essential.

So it’s not just about tumor control anymore?
Exactly. It's about enabling people to function—to work, to think clearly, to enjoy life. We’re not just buying them time, we’re preserving who they are. That’s why radiosurgery must be done with the highest level of precision. It’s ablative—it destroys tissue—and the brain doesn’t forgive mistakes easily. That makes the responsibility very real.

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About Naren Ramakrishna, MD, PhD

Dr. Naren Ramakrishna is the Director of Proton Therapy and Neuro/Pediatric Radiation Oncology at the Orlando Health Cancer Institute in Orlando, Florida. He also serves as Co-Director of the Brain and Spine Tumor Program. With decades of clinical experience, he has contributed to national and international treatment guidelines, including ASCO recommendations for brain metastases. As one of the original contributors to the Novalis Certified Program, he has helped shape global standards for safe and effective radiosurgery.

You’ve been involved in the Novalis Certified Program, which strives to standardize quality in radiosurgery worldwide, since the beginning. Given the developments you have just described, it seems that this quality is more important than ever.
Quality has always been of the utmost importance. As I just said, radiosurgery is a very powerful tool, but if done incorrectly, it can be dangerous. That’s why it has always been the goal of the Novalis Certified Program to ensure that radiosurgery is done safely and according to high clinical and technical standards. It’s not just about having the right tools. It’s about using them properly, in ways that protect the patient.

But aren’t there already standards in place? Regulatory checks, FDA approvals…
Yes, but they don’t go deep enough. Radiosurgery is incredibly complex. That’s why we wanted to create a structured process to assess and improve how radiosurgery is delivered—both technically and clinically. And we’ve seen that even good clinics can always improve. This isn’t about labeling places as ‘good’ or ‘bad’ – it’s about continuous quality improvement.

You said earlier that radiosurgery is ablative. Does that make it more risky than other forms of radiation?
It does. In conventional radiation therapy, there’s usually some margin for error. With radiosurgery, there isn’t. You’re delivering a very high dose to a very small area. So even small mistakes in targeting, dose calculation, or timing can lead to serious harm—especially in the brain. That’s why quality assurance is so essential.

Do you think all practitioners are aware of that responsibility?
In general, yes, of course. But as radiosurgery becomes more common, there's a risk that it gets treated like routine. But it isn’t. And I think those of us who were around when it was still new—who’ve seen what happens when it’s done wrong—we remember. That’s why I sometimes say: we in the Novalis Certified group are the guardians of radiosurgery. We know the risks. We’ve seen the consequences. And we work to make sure others don’t have to.

Today’s software seems to do a lot of the planning work. Does that help mitigate the risk?
It does, to a point. What Brainlab is doing—integrating treatment histories, modeling cumulative dose over time—is remarkable. It helps centers maintain safety. But you still need clinical judgment. You still need someone who knows which questions to ask. No algorithm can yet replace that. Especially when patients have had prior treatments, underlying conditions, or genetic predispositions that affect their response.

You mentioned that people with cancer are living longer. As patients return for treatment again and again, does the complexity of treatment also increase?
Absolutely. More patients survive their primary disease and come back for treatment of additional brain metastases – or even treatment of side effects from previous treatments. So we’re dealing with brains that have already seen radiation, sometimes multiple times, and we need to balance aggressiveness with safety. There’s no one-size-fits-all anymore. That makes clinical experience, thoughtful planning, and structured quality assurance more important than ever.

You mentioned side effects. Are those becoming more relevant as patients live longer?
Very much so. In the past, if someone was only expected to live a few months, we accepted certain risks. Now, the long-term effects matter a lot more. Cognitive decline, radionecrosis, vascular damage—these are not just theoretical risks. They are real concerns. And because of that, we need to be as careful as possible in our treatment strategies. Again, that’s where experience and protocols like Novalis Certified play a critical role.

So what exactly does the certification look at?
It starts with the basics—how the department is organized, how often they review cases, how many physicists they have per treatment volume. Then we dig deeper: is the machine calibrated properly? How is stereotactic accuracy established and maintained? How are complex cases handled? We’ve seen all kinds of variation. Sometimes the dosage or fractionation strategy isn’t optimal. And these things matter—they can directly affect patient outcomes.

Let’s talk about patient outcomes. Have you seen a difference in results between centers that have gone through the Novalis Certified process and those that haven’t?
What we’ve seen—anecdotally but consistently—is that centers engaged in structured quality programs tend to catch more errors before they reach the patient. That could be something as simple as an overlooked calibration schedule or as complex as suboptimal treatment planning for large or re-irradiated lesions. When those things are identified early, they can be corrected. And that leads to better patient safety—and, in many cases, better outcomes.

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Novalis Certified is an independent certification program dedicated to high standards in patient safety and treatment for stereotactic radiosurgery and stereotactic body radiotherapy.

Do you get feedback from the centers you audit? How do they respond to the process?
Yes, very often. Initially, there’s sometimes concern that we’re coming to evaluate them in a critical way. But the process is always collaborative. And in most cases, people appreciate the input. They want to do the best for their patients—they just don’t always have access to international best practices or peer benchmarks. When we can share those, it becomes a learning moment for everyone.

Would you say Novalis Certified is more about people than about machines?
Absolutely. It’s about raising the standard of care, not just the technology. You can have the best tools in the world – but if they’re used inconsistently or without full understanding, patients are still at risk. This is also something that I find very remarkable about Brainlab, on whose initiative the Novalis Circle and the Novalis Certified Program are based: that they have a genuine interest in ensuring that their products and solutions ultimately provide the best possible impact for patients and really make a difference.

Is that what keeps you motivated to stay involved in the Novalis Certified Program—even after 15 years?
First of all, it's a way to share insight on a global scale. I can help my patients locally—but through this program, I help raise the standard internationally. That means better outcomes, more safety, and ultimately: better lives.

What’s your vision for the future of radiosurgery?
That we move beyond just physical dose planning to a biological understanding of how tissue responds to treatment. We’ve done well with physics. But the next frontier is biology. If we get there, radiosurgery will be safer. And more effective.

The statements made by the healthcare professional during this interview represent their personal opinion and experiences. These statements may not be supported by scientific evidence or peer-review research. For verified information about the device, please refer to the manufacturer’s official documentation or consult clinical guidances.

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