Thallium-201 returns to US market for cardiac imaging
Curium has announced the immediate reintroduction to the U.S. market of its cardiac nuclear imaging radiotracer thallous chloride TI 201 (thallium-201). The single-photon emission computed tomography (SPECT) tracer ceased production in 2022, but has has been reintroduced due to regular, repeated shortages of the primary SPECT tracer technetium-99m (Tc-99m).
Curium also produces a Tc-99m sestamibi kit for cardiac imaging in the U.S., so it will now offer thallium as an alternative.
“Restoring access to thallium-201 expands clinicians’ diagnostic options, particularly when PET or MRI is not available, or when sites need an alternative for stress testing," Andrew J. Einstein, MD, PhD, director of nuclear cardiology, cardiac CT and cardiac MRI at NewYork-Presbyterian/Columbia University Irving Medical Center, said in a statement. "For select patients, thallium-201 can support timely, actionable imaging when operational flexibility matters, helping to reduce uncertainty so care teams can make confident, time-sensitive decisions and move quickly to the most appropriate next steps.”
Thallium-201 was first approved for clinical use by the U.S. Food and Drug Administration (FDA) in 1982 when the agency cleared a new drug allocation submitted by Bracco. The tracer was also made by GE Healthcare, Lantheus and Curium. Trace Life made a generic version the tracer starting in 2001. Lantheus was the last company to discontinue production in September 2022.
The radiotracer was used less and less over the past few decades as more imaging centers switched to Tc-99m, which offers lower radiation dose imaging. However, newer cadmium-zinc-telluride (CZT) SPECT digital detector technology can enable ultra-low dose thallium-201 imaging.
Curium said its decision to reintroduce this tracer to the market was based on feedback from the nuclear cardiology community.
“ASNC is delighted that thallium-201 has become commercially available again," said American Society of Nuclear Cardiology (ASNC) President Jamieson M. Bourque, MD, MHS, FASNC, in a statement to Cardiovascular Business. "Although the majority of patients undergoing SPECT perfusion imaging should continue to receive Technetium-99m, there are select clinical scenarios - such as viability assessment or simultaneous dual isotope imaging in amyloidosis - where the additional tracer option is beneficial. Commercially available Thallium-201 increases clinical options and patient access and supports ASNC’s goal of patient-centered care.”
“When clinicians express they are facing a real gap in care, our job is to help close it," said Mike Patterson, Curium North America’s chief executive officer, in a statement. "We are proud to collaborate with leaders in the community to make thallium-201 available again and restore access."
He said the reintroduction required specialized infrastructure, cyclotron investment, manufacturing readiness, staff training, and added quality control resources to help ensure a reliable, long-term U.S. supply. The tracer will be produced at Curium’s Maryland Heights, Missouri, facility.
Thallium-201 has a half-life 72.91 hours, enabling it to be easily transported to sites across the country from the St. Louis area-based cyclotron.
Thallous chloride Tl 201 injection is indicated for myocardial perfusion imaging in adults with planar scintigraphy, or SPECT for the diagnosis of coronary artery disease. It is specifically indicated for three diagnostic areas, including localization of non-reversible defects caused by myocardial infarction, which may have prognostic value regarding survival. Identification of reversible defects caused by myocardial ischemia when used in conjunction with exercise or pharmacologic stress. And localization of sites of parathyroid hyperactivity pre- and post-operatively in adults with elevated serum calcium and parathyroid hormone levels.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]