Lucerno Dynamics pushes for stronger reporting of nuclear medicine mistakes

The head of Cary-based Lucerno Dynamics, a small medical technology company with a stake in nuclear medicine, is urging stronger federal regulation of radiopharmaceutical injections to support patient safety, care and transparency.

Ron Lattanze, chief executive officer of Lucerno, wants the Nuclear Regulatory Commission (NRC) to require nuclear medicine centers to report cases of faulty injections as “medical events.”

Injections of radioactive pharmaceuticals, such as those used for PET scan and CT scan imaging, are intended to go into the bloodstream through a vein but sometimes miss their mark, depositing radioactivity in surrounding tissue. These unintentional mistakes are known as radiopharmaceutical extravasations or infiltrations.

“Radiopharmaceutical extravasations are an insidious medical error,” Lucerno said in a news release. “Evidence proves that large extravasations of high-energy therapeutic or even low-energy diagnostic radiopharmaceuticals can cause tissue and skin damage over time and compromise the nuclear medicine procedure.”

Regulatory changes proposed

The NRC requires nuclear medicine providers to report medical events that result in unintended radiation exposure to a patient’s tissue over a certain limit. But due to a loophole, extravasations — no matter their severity — have been exempt from this reporting requirement since 1980. As a result, neither patients nor physicians are notified when a patient is exposed to radiation that far exceeds NRC limits.

Proposed regulatory changes, published by the NRC in August, would partially close the 44-year-old reporting loophole and require diagnostic and therapeutic extravasations that have caused injury or have the potential to cause injury to be reported as medical events.

The changes, drafted after Lucerno petitioned the NRC, would be “positive steps for patient safety, improved care and transparency,” Lattanze said.

However, he said the agency “needs to go further, move faster” to strengthen the proposed regulations, which are “watered down by using harm and subjective physician determination to guide reporting.

“This is not the way NRC approaches other accidental exposures, and it is just not good enough. Thousands of patients continue to experience large extravasations every day.”

One patient who experienced negative effects from an extravasation is Raleigh resident Pam Kohl, a breast cancer patient and advocate who is involved in the Patients for Safer Nuclear Medicine coalition. In an opinion piece published April 12 in STAT, an online health and medicine news site, she and coauthor Dr. Bill Kiser, a radiologist, argue for more transparency and accountability that stronger NRC regulations would bring.

“If a patient is accidentally irradiated above NRC’s dose-based threshold, that incident should be reported, regardless of how it happened,” they write. They dismiss “entrenched interests” within the medical profession that want to keep the status quo.

The Society of Nuclear Medicine and Molecular Imaging, the American Society of Nuclear Cardiology and the American College of Nuclear Medicine have jointly stated a position that no additional rulemaking for extravasations is required for patient safety.

Some health care and life sciences professionals have posted similar positions on Lucerno’s LinkedIn page, questioning the prevalence and impact of extravasations and the need for greater regulation.

Company presses on

“While I am happy that NRC is headed in the right direction, I am sure that patients, their physicians, international radiation protection organizations and global experts will agree with me that more is needed,” Lattanze said.

He thinks the NRC should follow the lead of the International Atomic Energy Agency and the International Commission on Radiological Protection, both of which recommend monitoring for extravasations during radiopharmaceutical administrations and reporting extravasations that exceed a certain radiation dose.

“A dose-based reporting threshold is best for reporting and for the patient,” Lattanze said. “The most objective and effective way to assess the effect of a radiopharmaceutical extravasation on the patient and their procedure is to characterize the extravasation using dosimetry.”

About 30 million nuclear medicine injections are given annually in the United States, and about 4.5 million patients experience extravasations, according to Lucerno, which estimates that 500,000 of those extravasations are “significant” events that can compromise a medical image and possibly leave damaging radiation in a patient’s arm.

“Patients want to know how the severity of an extravasation could affect their health, as well as their image or therapy procedure,” Lattanze said. “And all of this information needs to be documented in the patient’s medical record. It is a basic patient right.”

A bill that would require the NRC to revise its regulations on nuclear medicine procedures has been proposed in the House of Representatives but has not yet come to a vote. The Nuclear Medicine Clarification Act of 2023 was introduced by Reps. Don Davis of North Carolina and Morgan Griffith and Ben Cline of Virginia.

Lara System addresses the issue

Lucerno has a vested interest in nuclear medicine and its regulation. The company specializes in the design, development, manufacture, marketing and distribution of systems to detect the presence of radiolabeled biomarkers.

Lucerno’s Lara System is designed to help clinicians monitor injection errors of radiopharmaceuticals within minutes at the patient’s bedside. The noninvasive medical device is designed to help identify contributing factors in extravasations, lower the rate of such errors and reduce the incidence of compromised scan images.

Founded in 2011, Lucerno received early financial assistance from the North Carolina Biotechnology Center to develop and commercialize its technology. The company received a $150,000 Small Business Research Loan in 2014 and a $300,000 Strategic Growth Loan in 2016.

NCBiotech has also funded multiple internships at Lucerno through its Industrial Internship Program.

“NCBiotech was an early supporter of Lucerno’s technology, and we have been impressed with the company’s persistence in addressing some of the policy and regulatory challenges in this area,” said Erin Kaltenbrun, Ph.D., director of investments in the Emerging Company Development unit at NCBiotech. “This regulatory change represents an important milestone for Lucerno and will help to bring their innovative technology to nuclear medicine patients across the U.S.”