Nuclear medicine injections are often used in cancer screenings: What happens when it goes wrong?

Treating cancer that has spread to other parts of the body often includes PET scans or bone scans.

Both use radioactive medicine, injected into a patient’s bloodstream through an IV in their arm, to help doctors spot where cancer has metastasized.

If a drop of that medicine falls on the floor, or even on a patient’s gown, institutions are legally required to report it.

However, if the injection goes wrong and medicine winds up in a patient’s tissue instead of their bloodstream, those patients are often never told.

“For me, it was burning,” said breast cancer patient Pam Kohl. “I’d had this done enough to know it shouldn’t be burning.”

Kohl recalled the atypical sensation she felt when she first realized she had experienced what is called an extravasation. Kohl has received nuclear medicine injections every three months for the past seven years as part of her routine scans.

“I said to the technologist, ‘Something is wrong’ and they said 'No, everything is fine, I got blood return,'” Kohl explained. “In many situations when you get a scan, your arms are out of the field.”

Kohl persisted and told WRAL News she convinced the technician to place her arm under the X-ray as well.

“Sure enough, once I convinced them to do that, there was a big blob of nuclear medicine in my elbow area," she said. "It had not gone through my bloodstream.”

Kohl’s experience is atypical. Most patients don’t have any immediate symptoms of an extravasation and can be unaware that an injection went wrong.

It’s why Kohl is vocalizing her support for the Nuclear Medicine Clarification Act of 2023.

The bill is sponsored in-part by U.S. Rep. Don Davis, D-North Carolina. It would require the Nuclear Regulatory Commission to “revise its regulations to protect patients from unintended exposure to radiation during nuclear medicine procedures, and for other purposes.”

“You’re in a gown. You’re depending on your doctors; you’re depending on all the people around you to take care of you,” Kohl said. “It’s hard to advocate for yourself and you want to trust.”

Kohl said she hopes a legal requirement to report improper injections would cause institutions to better monitor the administration of the medication.

“Extravasation is a problem that can be solved, both with technology and a commitment to patient safety first,” Kohl said.

Certain technology, like that created by Lucerno Dynamics, already offer a solution for institutions.

The Cary-based company developed a radiation detection device called the Lara System.

CEO Ron Lattanze explained the system utilizes two sensors, placed on each arm of the patient, to monitor radiation levels immediately after an injection.

“After the injection passes by the first sensor, after about twenty seconds, they should be reading the exact same amount of radiation if it’s circulating properly,” Lattanze said. “You would know immediately if you’ve got a problem.

"Our technology shows you a real-time count of how much radiation is coming out of the injection sensor versus the other sensor.”

The Lara System has been used more than 35,000 times across the globe. The company found 17.5% of patients who undergo nuclear medicine procedures are extravasated.

Lattanze explained the goal of the system is to alert doctors sooner of potential problems with an injection so that mitigation efforts can begin.

“Today, patients don’t know when this is happening," Lattanze said. "I’m going to make the statement most patients don’t even know they’re being injected with a radioactive drug.”

When radiation doesn’t spread properly it can cause a scan to be inaccurate.

Lattanze explained an estimated 30,000,000 nuclear medicine injections happen each year in the United States. Of them, roughly 500,000 will involve extravasations that will compromise the scan and potentially leave large amounts of radiation in a patient’s arm.

“If the technologist and the interpreting physician, the radiologist or nuclear medicine physician, don’t know the patient has been extravasated and they see perhaps a low-quality image but they don’t know what’s causing the low-quality image, they can actually reach the wrong conclusion about the status of the patient’s disease and whether it has spread or not,” Lattanze said. “That’s a big concern.”

The Nuclear Medicine Clarification Act has been introduced in the U.S. House but hasn’t been brought up for a vote.

Kohl and Lattanze both expressed optimism that it could pass and one day become law.

“No institution wants added regulation, but this is an easy fix for patient safety,” Kohl said.

“If hospitals are incented to actually start monitoring for extravasations, what will happen is they’ll start tracking them and they’ll see how often it does happen,” Lattanze said.

Lattanze said his company’s technology is just one of multiple ways institutions could begin the path toward becoming more accountable.

“I hope the impact of our technology is that fewer patients will be extravasated and nuclear medicine will produce higher-quality images that in the long run are great for patients and nuclear medicinem” Lattanze said.