Does Increased Infiltration Reporting Correlate with Better Outcomes?

Although H.R. 2541, the Nuclear Medicine Clarification Act of 2025, purports to increase transparency in reporting radiopharmaceutical leakage, Thomas Hope, MD, vice chair of Clinical Operations and Strategy and professor in the Department of Radiology at the University of California, San Francisco (UCSF), is unsure what clinical issue the bill is seeking to remedy.

In an interview with CancerNetwork®, Hope discussed the background of the legislation, as well as the benefit it may seek to deliver for patient outcomes. Although Hope acknowledged the incidence of dose infiltrations, whereby nuclear material exits the vein and leaks into local tissue, in his experience, he has not observed a single adverse effect (AE) associated with such an event.

Addressing the aim of the bill, Hope posited that infiltrations may happen with any intravenously delivered medicine, and that reporting requirements may help to better track their occurrence. However, he questioned whether effectively tracking the incidence of these events would fix any clinical issues.

Transcript:

[H.R. 2541] is trying to increase the reporting requirements for, in essence, nuclear medicine when they administer radioactive compounds through an IV into an arm. The idea here is that when you inject anything through an IV, sometimes, it goes directly into the vein throughout your body, as it's intended to. Other times, it can stay in the arm, what we call infiltration. It leaves the vein and then it goes out into the tissue in the arm. That can happen with any type of IV that is being administered. [It can happen] with chemotherapies, it can happen with intravenous contrast for CT or MRI, and it can also happen in the setting of radiopharmaceutical administrations. Infiltration is a common issue. This bill is trying to increase the reporting requirements so that, presumably, we can track this better.

A better question is, what's the clinical problem it's trying to fix? Do we have an issue with infiltrations out there? Is there a high incidence of this with [AEs or] patients having injuries to their arm because of infiltrations in radiopharmaceuticals? I would probably argue, no. At UCSF, we do 10,000 PET-CTs a year [and] nearly 1000 therapies with therapeutic doses a year, where we use IVs [and] administer radiopharmaceuticals––and I have actually never heard of a single case of an [AE] in the 10 to 15 years I have been working at [UCSF]. The goal of the bill is to increase reporting requirements, but I am not sure what it's trying to address. Is there a clinical problem that we need to fix because of these increased reporting requirements?

Reference

H.R.2541 - Nuclear Medicine Clarification Act of 2025, 119th Cong (2025). Updated April 1, 2025. Accessed October 17, 2025. https://tinyurl.com/33n97vjr