Launching Maskless Treatments

Crystal Sulaiman (00:04):

As Menna just said, I’ll be talking about our maskless treatment, which is not strange or anything to most people in the room, that this is the new up and coming thing that a lot of clinics want to adopt. Some have already adopted, some have already treated patients. So it’s a really exciting time I think in SGRT right now that we are able to do such studies. So exactly that’s our study and it’s looking to really compare a closed mass, a five point mask treatment, with maskless treatments, with the aid of SGRT. And so our two objectives for our study are looking at, firstly, comfort and preference, and the second is accuracy. And the reason why these are not flipped, as maybe some of you would be wondering is because we only actually have a patient. We only have 25 patients in our study, so it’s quite small. It’s definitely still an intro. In order to have accuracy as your primary objective, you’d need to recruit many more patients. So again, this is just kind of dipping our feet in the water.

Crystal Sulaiman (01:08):

Briefly, what I’ll be speaking about today. So I’d like to start off with the who. So who is actually involved in the interdisciplinary team in all studies. And I’d just like to really highlight here, the two main people to shoutouts is Katerina, who is a fellow RTT with our team, who kind of already started the background research of this study way before I was on the project, and she couldn’t be here today. So thanks to her and all the work that she put in. And the second person is Deborah from our study office, who I think this project would’ve taken much longer than just what we’ve got. Because she was constantly replying to our emails daily. She was answering calls, she was giving us templates and really being active in the whole process, which is the part that takes the longest.

Crystal Sulaiman (02:01):

So yeah, big shoutout to her and keep your relations with your study office and your departments quite strong because you’ll need them. The why I think this is pretty self-explanatory. We obviously know that patients have expressed or maybe have not expressed, but that they feel maybe uncomfortable or anxious in a mask system. I think we often talk about patients who already speak about claustrophobia, but what about the patients who actually go into the treatments having no problems, but saying towards maybe the end of their treatment. You know, I think it was maybe not going to be so bad, but every time that mask came on, it kind of induced a bit of anxiety in me. So kind of focusing on all patients and what we can do to, to help them in that regard. And I think another point would be maybe to reduce materials and time.

Crystal Sulaiman (02:53):

We know that all products that are medical devices are quite expensive, so eliminating them could be something for clinics. Time, of course, our CT simulation slots are not getting any shorter or getting longer. Sorry, they’re getting shorter. So that could be something for clinics that are quite busy. Could we potentially reduce skin dose by eliminating that mask? And of course, new standards take quite a long time. So just because we have, I don’t know, maybe five clinics that are showing that this kind of procedure works, of course, we can adopt it as a new standard right away. But what about palliative patients? Could this be a reality for them? Can we really eliminate the need for such interventions in immobilization? The, how this is kind of a the slide looks a little bit different than how I made it, but it’s a visual representation of kind of all the work that went into yeah, that went into it.

Crystal Sulaiman (03:55):

Sorry, it doesn’t really make any sense there because it all got moved over. But essentially the whole year of 2024 was the, was the preparation. So really all of the documents that were required to get the ball rolling was a constant sending, reviewing, editing, going back and forth between the course study team and the study office. Those documents then got submitted in January of 2025. So at the start of this year to the ethics commission in Zurich. The approval process then took roughly around four months. So there was in a, a revision that was made in March. And then of course, the study was approved the 15th of April. And then of course, between approval and actually opening the study for recruitment, there was a few fine-tuning tweaks that we needed to do. Of course, rollout training.

Crystal Sulaiman (04:48):

So for our clinic that took roughly a month. I’m not sure if that’s quick or if that’s long for some clinics who’ve already had experience with that. And then the, the actual study opened the 13th of May and recruited its first patient, the 14th of May, so one day later. So again, things move very quickly in Zurich. And our study recruitment is looking again to recruit 25 patients, so not a crazy amount. And that will be open for roughly around two years’ time. The documents, I’ll just in the respective time, kind of quickly go through them. I think what documents you’ll need to prepare may be different based on the country that you’re working in and what are the requirements are, but just generally the clinical study protocol is the meat and potatoes of the thing. So this is quite a lengthy document which really goes through what are the objectives, what are the inclusion and exclusion criteria procedures, assessments, schedule all that.

Crystal Sulaiman (05:49):

The case report form or the CRF is a document that has all of the patient data where you document any adverse events and such on the patient information consent. So what really a layman’s terms of what the study entails for the patient in their respective mother tongue. So for us, this was translated in German. And then our questionnaires, which we created three different ones. And I’d like to reference our in-house. So this was from the University Hospital of Zurich. It was an open face study that was presented here a couple years ago. These are similar questionnaires that they use because we’re looking to check for comfort and preference. And so this is the first one is a baseline at simulation. The second one is given weekly, and the last one is the last day of preference a patient database.

Crystal Sulaiman (06:41):

So really just an easy Excel list that keeps track and records of all the patients that we have in enrolled. All of the results. So from CBCTs, how many shifts, the questionnaires just to kind of have everything in one space for a quicker assessment at the end when we’re looking at the results the how. So again, between approval and actual recruitment, there was one month time where we really had to finalize everything. And lucky for us, we were told that our clinic was going to get a free max MR. I’m not sure if anyone’s familiar with that. So that’s a 1.5 Tesla where we’re looking to do offline adaptions. As our MR Linac is slowly losing its shelf life, so to speak.

Crystal Sulaiman (07:38):

And so we had to actually train our staff with a completely new mask system which would be compatible then with all of our MRS and CT and machines. And that’s the white masks that you see there. So our setup looks maybe quite different than what other people have seen. So there are thermoplastic masks that other clinics have used. We do not have that because we are we don’t have MacroMedics. And so we’ve used actually the AccuForm cushion, which is the head, neck, and shoulders from CQ Medical. And underneath that, what you don’t see is a carbon Kyle. So the Kyle or the wedge on the thicker end is actually caudally and is used to ensure that the patient’s head is quite neutral. And we know with SGRT that having an inclination or a reclamation of any body part causes shadowing.

Crystal Sulaiman (08:31):

So the cameras don’t quite like that. So that was the main goal of the head position. The AccuForm cushion, I’m sure many of you are familiar with that really builds it up to mid body. Because that’s where we typically stop our ROI’s when we draw them. And really making sure that there’s no air gaps or there’s no yeah, that it’s quite clear on the machines where exactly we are. We also introduce this later on in the study. We started marking on the cushions where the ears are to kind of get a longie of the patient in the cushion, the five-point masks. Everyone knows how to fabricate those. And then, yeah, I’d just like to highlight on this slide how important it is to have a precise simulation. So we have had a few patients where we had to re-sim them due to again, kind of training competency.

Crystal Sulaiman (09:23):

Some patients had MR-only workflows, so the masks were fabricated in MR versus in CT. So the easier the sim, the better the simulation is, the easier it will be for treatment, that’s radiotherapy 101. Testing the ROI. So we did get in touch a lot actually with AlignRT, who gave a, gave us a lot of good tips and tricks about kind of where to start. And I think what’s important to note here is that for our study specifically any patients with nasopharynx or a sinus involved treatment were is an exclusion criteria. So we’ve decided to actually eliminate having the orbit is in the ROI. We focused on bony landmarks such as the nasal bridge, the chin, the sternal knot, the clavicles to have the shoulder information. Again, we’ve taken the ROI to midline.

Crystal Sulaiman (10:14):

And in this example you can see that we’ve actually taken the larynx out. So of course if we were treating a larynx patient, which we, we did, we have so far, that would obviously be included. So we know that one can swallow independently of moving. So we weren’t worried about eliminating that from the ROI. And just to say here that it’s important to keep the ROI as standard as possible to have, you know to, to be able to kind of compare all these patients. But what we have realized is the head and neck is quite a long region and the Isocenter can, can quite vary. So, for example, we had a thyroid patient where the isocenter, so we took the ROI and extended a little bit farther down. And the second thing to note here is that I think other clinics or other studies who’ve done this have tried a two ROI approach where you have a setup ROI and then you have an actual treatment.

Crystal Sulaiman (11:11):

ROI, we decided against that because our clinic is not so big, but 25 radiation therapists who are constantly switching machines. So we don’t have rotations of three, four months. We’re going back and forth, sometimes multiple machines per week. In addition to the fact that the radiation therapists have a wide range of expertise. So some are very advanced, some are very beginner. So to kind of help the workflow streamline and be as easy as possible we decided for the one ROI approach and then again, before we could get started, we had to streamline the workflow. Which you see on the right-hand side, I apologise. Both of these documents are in German. But very quickly in the setup in the room, we use the posture alignment very at the very beginning where that’s giving us a general idea of where the patient is lying.

Crystal Sulaiman (12:03):

Then we move on to, of course our deltas. And of course these, these are average values based on this one ROI. So we are adjusting our vertical long nad lat with the pendant. We’re going to the patient for rotation pitch and roll. That’s where deformation comes in. It’s very, very useful specifically for this region where you can see that you need to relax the shoulders down, you need to roll the head in one specific direction and you kind of just keep repeating that until you’re happy with the position before leaving the room. This obviously took some getting used to, of course the first few patients took a bit longer. But I think now that, you know, the team is quite used to the, to the workflow and the process I think we have definitely gained some time. And then before we leave the room, of course we, you know, use treatment captures to again check that everything looks okay.

Crystal Sulaiman (12:52):

And then we do a center couch quickly to make sure our values are as close to zero as possible. We then take a reference capture before the cone beam to ensure that between the cone beam and treatment that the patient hasn’t moved, then we match, we shift, we’re happy with that. And then before we actually start with treating we decided that instead of doing a reference capture, we’ve actually decided to do a gating, a gated capture. And so this was decided after our first patient. It was spoken, discussed with our physics. And what we decided to do is actually place the point of the gated capture on the sternal notch, because that was a stable point. And that gave us a more accurate capture because we noticed that breathing and swallowing actually impacted the beam stoppage than we thought it would.

Crystal Sulaiman (13:41):

And the gated capture really allowed us to kind of treat without any major issues. Of course, if the patient’s moving, it’s going to stop. But this was a much more accurate, I think, description of like the actual patient movement. And then yeah, we treat and our tolerances for the aligner T are two millimeters and two degrees. And of course if the patient moves during, we would, you know, take a new cone beam as yeah, as one would. On the right-hand side is our IGRT document. So that’s an image-guided document that we have for all of our patients. This is specifically useful for a study patient because we have kind of summarized on it what the study entails, what we should do with troubleshooting, what randomization arm is the patient, in what date do we switch the setups and when we give the, when we give the questionnaires, when we do the post-cone beam.

Crystal Sulaiman (14:40):

So I think we’ve tried to simplify it as much as we can for the radiation therapists. And it’s been working well so far training and competency. So again, in this month phase where we’re still trying to get everyone on the same page we did a, or we had a kickoff meeting that was specifically for our study group. So the core team where we signed the delegation logs and training logs. So everyone was kind of aware of their roles and expectations. That moved on to an internal clinical research meeting where all doctors, all physicists, all the study team was then involved and given an intro to the study. And they were actually quite receptive to it. They were quite positive about, you know, launching the study in our department. And then lastly were the education and training sessions with the RTT specifically.

Crystal Sulaiman (15:35):

So these were done over lunch periods. There were multiple, so for yeah, focusing on simulations, set up workflows, we kind of opened the floor to the RTTs outside of our core team of three to ask for, you know, their advice, their expertise and kind of again tweaked our ROIs and tweaked our workflows based on their feedback ongoing is a in-house good clinical practice course. Maybe some of you who are involved in research are familiar with it. It’s mandatory for anyone who’s doing research at our hospital to partake in that. It’s two modules. And it’s just a general overview of what’s involved in research, what’s expected, and yeah, so I can’t unfortunately share any results just yet. But we have currently as of now enrolled 11 patients, eight have already been treated, and three are currently under treatment.

Crystal Sulaiman (16:33):

And I think, you know, with every patient we keep learning more and more and we keep fine-tuning things as we go. Every patient’s anatomy is different. Every patient’s needs are a little bit different. And I think just very generally, we’re comfortable with setting patients up with masks. What we do see is in the late latter half of treatment that starts being difficult to close the mask they start having side effects, the swelling. And so that’s where I think the maskless variation is quite advantageous. They don’t need that. You can detect swelling, you can create new SGRT body references with yeah, with your system to more accurately set up from the outside. Things like placing a bolus, there’s no need to cut masks. You can place the bolus directly on the skin, eliminating air gaps. We’ve already had I think maybe three or four of these 11 patients with custom boluses.

Crystal Sulaiman (17:30):

Which at first we thought, oh no, but then we thought we saw that it was working quite well. And I think again, just keeping similar staff you know, treating a patient for seven weeks in a row, you kind of know exactly what you need to do because patients move in similar ways. I think that’s quite helped with time. Of course, I can’t say now because we haven’t looked at the results, but I think, you know, the treat the allotted time for no mask patients and normal patients is not different. So all patients still get 15 minutes and we’re able to on a good day or on a non post CBCT day, get them in and out in roughly 15 minutes. And what we did really notice not surprising to us, but how much swallowing and breathing really impacts movement.

Crystal Sulaiman (18:17):

So we are having to monitor the patients more closely because we were eliminating the mask, which maybe can be seen as a con, but of course we should be, you know, moderating the patients anyhow. Maybe that takes this laziness out and refocuses our attention on the patients instead of chit-chatting at the console. And the other thing that we noticed is that, of course, our patient cohort is quite old. We’ve seen that sleeping patients, some of them just fall asleep during the treatment, and that causes a lot of, you know, this dropping of the chin. Which, yeah, is just interesting to note. But I think the main point is to really explain to the patients how important it is to kind of stay as still as possible, maybe to focus to look up and to focus on a particular point at the ceiling to try to remain still.

Crystal Sulaiman (19:10):

Yeah. And the final takeaway here is of course, with anything, anything new, anything with a large team, it takes a village of people to get it going. The specific takeaways for me personally, I think, and from the team is that patient selection is really important. So I think of course, we want the patients to comply with what we’re doing. We are quite lucky in Switzerland that most patients are very willing to follow rules to be punctual, to literally just do whatever we ask of them. Maybe in other countries, there’s a little bit more resistance to that. They need more time, they need more explanation. So that’s something to consider. Precise simulations, again, I spoke about that on the previous slide. The better your simulation is, the better your outcome is going to be. Easier it is to set up adhering to clinical specific protocols and workflows.

Crystal Sulaiman (20:05):

So again, the two examples that I mentioned, we, you know, received these new masks a month before we were start supposed to start recruiting patients, which was a big challenge. And then of course specifically for us, these MR only workflows. So our patients could have either a CT only, they can have an MR only or some in some cases they actually have both for planning. And so this means that we’re working with synthetic CTs, we’re image matching on synthetic CTs, we’re exporting synthetic CT contours and bodies. So this has all been kind of a learning curve as well. So far we haven’t seen any huge differences, but again, this is things that we’re going to have to consider at the results at the end, but could be good for centers who do a lot of workflows that we know that a massless treatment would be feasible in that kind of scenario.

Crystal Sulaiman (20:56):

Adaptability, as I mentioned, goes hand in hand. Continuously problem-solving, looking at the patients, their needs. How can we adjust things. For maybe two just specific examples, again here, switching from a treatment capture to a gated capture was what we thought in our physics thought was more applicable, was more relevant. And again, this one-size-fits-all ROI sounds nice in theory but maybe is not always the case. So that there are, you can adjust, you can go off kind of a bit of this standard to fit the specific scenario, the specific patient. And then I guess just to end is SGRT user variability? I think as I mentioned previously, clinics have lots of radiation therapists, lots of years of experience, some more, some less. And you can have workflows and protocols in place, but at the end of the day, no two people are going to use the system in the exact same way.

Crystal Sulaiman (21:54):

Of course, we want to get to the same endpoint, but I just want to highlight here how important it is to kind of make sure that the training and the competencies up to par with what you want to achieve. Because, you know, this whole study does really rely on using this system to its advantage and really using all the tools, as I mentioned, postural and deformation and getting everyone on the kind of same page. So yeah that’s everything. Sorry that I kind of rushed through that because I thought there would be no time for questions. I’d just like to say thank you to the whole team. I’m just one part representing everyone in Zurich and also to align our team for their help and their support. They’ve been really great at giving us tips and tricks and just kind of giving us the courage to do something that seems a little bit scary. So yeah. Thank you.