New Legislation May Help Reduce Extravasation Rates in Cancer Radiology

Jackson W. Kiser, MD, diagnostic radiologist and chief of Molecular Imaging at Carilion Roanoke Memorial Hospital in Roanoke, Virginia

In an interview with CancerNetwork®, Jackson W. Kiser, MD, diagnostic radiologist and chief of Molecular Imaging at Carilion Roanoke Memorial Hospital in Roanoke, Virginia, spoke about the Nuclear Medicine Clarification Act of 2025 (H.R. 2541), which is seeking to close a regulatory loophole that may result in the underreporting of extravasations following the administration of radiotherapies.¹

Initially, Kiser outlined the issue the bill is seeking to address, disputing claims from the Nuclear Regulatory Commission (NRC) that extravasations are unavoidable. In his own practice, Kiser explained that he utilizes a device that monitors his injections and records extravasations, and that his site has protocols in place to inform patients if they had an extravasation, repeat imaging at no cost if the image quality is unsatisfactory, and to provide follow-up to help mitigate long term adverse effects (AEs). Then, Kiser, expressed that extravasations are further amplified when using beta emitters, which can use a higher dose of radiation than a traditional PET scan, causing severe AEs such as skin necrosis.

Attesting that the impact of the bill would largely be contingent on NRC requirements for reporting, Kiser suggested that workflows would not be significantly impacted following the passage of the bill. Acknowledging the possibility that the legislation may take up more of a physician’s time and impact hospital budgets, he also described that workflows related to documentation would not be significantly upended and remarked that the installation of a monitoring device only takes seconds once one is accustomed to its use.

Kiser concluded by reiterating that a reduction in extravasation rate was possible, highlighting his own research to support the claim.² Therein, he assessed 5 technologists blinded to their injections, and after modifying their injection techniques, he observed a reduction in extravasation rates. This, he claimed, busted the myth that extravasations were unavoidable, according to a statement from the NRC in the 1980s. Finally, Kiser expressed that the bill could be impactful for clinical practice if Congress enables its passage.

What issue is H.R. 2541 seeking to address?

Kiser: One of the problems with molecular imaging, which encompasses nuclear medicine and PET imaging, is that we have to inject radioactive materials into a patient. Sometimes, these [materials] can go outside the vein and into the surrounding tissue. There are several issues with that. [First], you can have bad diagnostic quality images because the dose did not go where it was supposed to go. You are also irradiating the local tissue with high radiation doses depending on the isotope you are using.

What [the bill is] hoping to address is the fact that in 1980, the NRC stated that these extravasations occur in about 10% to 15% of patients to some degree [and] that these are unavoidable––there is nothing you can do to stop them––which is entirely false. [There are many] ways you can mitigate these things, but what the congressmen who presented this bill are looking to do [is have] it to be required to report these high-dose extravasations.

[Many] people deny that these even happen. But you can look at images and see extravasated material on a patient if that [injected tissue] is in the field of view; sometimes, it is not [visible] if you are just imaging [one] body part and the [extravasated tissue] is removed from the field of view. There is a whole lobby of people who are trying to prevent this from occurring, [requiring] that we would have to report these events.

In my practice, I have been using a device that monitors my injections, or my technologist’s injections, for 7 or 8 years, so we know when it happens and whether the injection site is in the field of view. When it happens, we can measure the dose to the local tissue. We have a physicist that can do that. If the image quality is not satisfactory, we will credit that patient’s exam and repeat it at no additional charge to them. We also tell the patient, which everybody else does to my knowledge, that if they did get extravasated, we would do follow-up calls to the patient to make sure they had no AEs from the injection such as redness of the injection site or pain.

Where it is [especially] going to become problematic is not just diagnostic [work]. We’re [also] infusing these extremely large doses of what’s called a beta emitter. It’s tagged to different types of pharmaceuticals, and instead of 10 millicuries, [which is what] we might inject for a PET scan, we are injecting 200 millicuries of beta emitter into these patients.

You can imagine, if that extravasated, that [the patient] can have some major issues such as skin necrosis. You may need to have plastic surgery [across] the area and do skin grafts. I require we monitor all these therapeutic injections as well as our diagnostic injections. That is what the [Nuclear Medicine Clarification Act of 2025] is stating: that we are going to be required to report these things to either our local health department, to the NRC, or to somebody [else].

What impact would the passage of the bill have on clinical practice?

It depends upon the NRC [requirements for] reporting methods. Is it going to be a visual assessment to put the injection site under the camera and see the extravasation, or are they going to require a threshold? If you inject over 2.5 Gy into the tissue, is that your threshold? But how do you determine that? You cannot make that determination quantitatively, [but] if they do make a quantitative requirement of these extravasations, [will there be a] device to help do these calculations, like the device I use to measure my injections going in or out? [Will there be] something where you put the injection site under the camera and measure the counts coming out of there? A physicist should be able to roughly determine what the issue is. But who are we going to report this to? Where do we record it? Do we put it in the electronic medical record [EMR]? Do we put it in the patient's chart? Do we just put it in the radiology report?

There are many details that have yet to be unraveled on the floor, and they are going to have to debate how to do these things. It will be interesting to see how this turns out because it could be impactful to the physician’s time. It could be impactful to hospital budgets and operations; [would] you have to buy a device that has disposables? All these things come into play, but it is going to have to wait for the final readout from the NRC.

H.R. 2541 aims to modify regulations related to EHRs. How might these changes affect the current workflows for documentation, data entry, and information retrieval within clinical practice?

It is going to depend; the physicians will not be bothered about any of the recording. That may be something that the technologist might enter into the patient record. I would have to be aware that this had occurred to tell the technologist to enter this into the records. It is not going to be [significantly] overwhelming or time-consuming to record this in the chart because the technologist [already] records things in the chart all the time about the actual scan; it would be one more little thing to add in there.

People say putting this [monitoring] device on interrupts your workflow. It takes 10 seconds to put this device on, so it really does not interrupt workflow at all––you could integrate this easily. There's always a learning curve once you start something like this up, but once you get a flow and get the muscle memory down, [it should be] easy because we do it on all our patients whenever possible. Some patients may come in if they have a chest port in or a permanent line, so we do not use it in those situations because we know that the catheter is where it is supposed to be.

There is one exception to that. We [perform] fluorodeoxyglucose [FDG]–PET scans for cancer, but we also do it for infection. One patient came down with a fever of unknown origin. They did not know why this patient was sick and having fevers, so we injected this patient's central line. It turned out they punctured through the vein into the chest and into the mediastinum, [where they] were dumping medicines. He had a chemical mediastinitis, and that's where his fever came from. We saw that even a central line can be screwed up, but those chest ports are usually reliable because they are put in surgically, and they know where it's going.

I do not think it will be too impactful to workflow. There will be a learning curve, depending upon how we are required to proceed. We will have to figure that one out as it comes.

Is there anything else related to H.R. 2541 that you would like to highlight?

Going back to the 1980s statement from the NRC, that [extravasation is] unavoidable––well, they are avoidable. You can train to prevent them. There is another paper we published looking at our extravasation rate before we had [the monitoring] device available.² The [technologists] would inject, and we had them blinded to their injections, so they did not know when they were extravasating or when they were not. We had about 5 technologists that were being monitored blindly, and we got a composite extravasation rate: it was about 13% to 14% of them, collectively.

We did a deep dive to figure out, “Why are you extravasating? Was it needle size? Was it patient weight? Was it patient age?” There were all these variables we looked at, and we found out some clustering of reasons for different technologists. We had to modify their technique in those situations. We measured them again, blindly, and they brought their extravasation rate down to approximately 2% to 3%. You can modify this, and you can do better; that is a “MythBuster” about the 1980s statements.

[H.R. 2541], depending upon how it reads, could be [quite] impactful. It’s good for patient care. It’s good for safety, image quality, and all these other things because you want that dose to go where it’s supposed to go, not into the [healthy] tissue at the injection site. It’s going to be interesting to see how this plays out, what happens with it, and how Congress will debate it and send it up to Senate. It’s going to be interesting to see how it goes, but I hope they do the right thing.

References

1. H.R.2541 - Nuclear Medicine Clarification Act of 2025. Congress.gov. Accessed April 17, 2025. https://tinyurl.com/mss6h3h5
2. Kiser JW. Quality improvement using new technology to assess and reduce FDG PET/CT radiotracer infiltrations. J Clin Oncol. 2018;36(30):313. doi:10.1200/JCO.2018.36.30_suppl.313